Blood collection safety devices and methods of use and manufacture

ABSTRACT

An automatically locking safety device, e.g., for use in a blood collection procedure, can include a housing, first and second needle covers that are at least partly received in the housing, and a needle that is at least partly received in at least one of the first and second needle covers. The needle can include a proximal tip configured for placement into a patient and a distal tip configured for placement into a blood collection vial. In some embodiments, the first and second needle covers are biased by a biasing member. In some cases, one or both of the first and second needle covers can be locked to prevent axial movement thereof after the blood collection procedure. In certain embodiments, a distal end of the device is configured to connect with a medical connector, such as a needleless IV access device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.15/847,574, filed Dec. 19, 2017, which is a divisional of U.S.application Ser. No. 15/268,132, filed Sep. 16, 2016, now U.S. Pat. No.9,848,810, which is a divisional of U.S. application Ser. No.14/185,281, filed Feb. 20, 2014, now U.S. Pat. No. 9,445,760, which is adivisional of U.S. application Ser. No. 13/483,878, filed May 30, 2012,now U.S. Pat. No. 8,663,129, which claims the priority benefit under 35U.S.C. § 119(e) of U.S. Provisional Patent Application No. 61/491,830,filed May 31, 2011, U.S. Provisional Patent Application No. 61/596,684,filed Feb. 8, 2012, and U.S. Provisional Patent Application No.61/615,783, filed Mar. 26, 2012. The entirety of each of theaforementioned applications is incorporated herein by reference.

BACKGROUND Field

Certain embodiments disclosed herein relate generally to bloodcollection devices and are particularly related to inhibiting accidentalcontact with needles in or on such devices.

Description of the Related Art

Blood analysis is an important diagnostic tool available to healthcareprofessionals. A significant aspect of modern medical care is theability to collect samples of blood for analysis. In some cases, bloodis collected by a syringe with a needle. The needle is inserted into apatient's vein and the plunger of the syringe is drawn back to aspiratea sample of blood into the syringe. However, operating the plunger whilemaintaining the needle in the vein can be difficult. Also, as thesyringe can only hold a single sample, multiple needle insertions may beneeded when more than one sample of blood is desired.

In other cases, blood is collected with a multi-sample sleeve, whichusually includes two needle ends. The first needle end is inserted intothe vein of a patient and the second needle end is configured to beinserted into a blood collection tube. Such blood collection tubes mayhave an evacuated chamber (e.g., containing a vacuum) and a self-sealingcap. When the blood collection tube is engaged with the second needleend, the needle pierces the self-sealing cap and the pressure differencebetween the evacuated tube and the vein causes blood to be aspiratedinto the tube. When the blood collection tube is removed from the secondneedle end, the self-sealing cap reseals the tube, thereby providing asealed sample of blood. Furthermore, the first needle end can bemaintained in the vein and additional blood collection tubes can beengaged with the second needle end to collect additional samples.

Due to the numerous potential hazards associated with the handling andmanipulation of bodily fluids, and particularly blood, there are anumber of safety features that can be incorporated into various types ofblood collection devices. For example, some blood collection deviceshave needles that are provided with a removable cap that generallyprevents needle sticks while the cover is in place. When the cap isremoved, the needle is exposed. These caps are removed before a bloodcollection procedure and replaced after the procedure before discardingthe needle. Among other concerns, this removal and replacement procedurecreates a risk of accidental needle sticks.

Some blood collection devices have features that a user must activate inorder to provide protection. For example, some blood collection devicesinclude a hinged arm that the user can press to cause the arm to swingover the needle. Notably, such “active” safety mechanisms are notengaged unless and until the user takes an action to specifically engagethe mechanism. In the stressful and fast-paced environment of manymedical facilities, e.g., emergency rooms, users can neglect to triggersuch active safety mechanisms, thereby rendering such mechanismsineffective.

Blood collection devices are frequently configured to be disposable;that is, they are intended to be used only once and then thrown away.However, some blood collection devices fail to prevent reuse or othersubsequent contact with the device, which can, for example, increase thelikelihood of transferring blood or tissue-born diseases from onepatient to another.

SUMMARY OF THE DISCLOSURE

In some embodiments, a first safety feature can provide selectivecovering and uncovering of a first needle. The first needle can beconfigured for insertion into a patient. The first safety feature canpermit multiple needle exposures until such time as the first safetyfeature switches into a non-return closure mode. This mode can beactuated in multiple ways, such as when the needle has been fullyexposed and then covered and/or when one or more other parts of thedevice have been actuated. In this non-return closure mode, the safetyfeature can lock permanently into place, preventing further needleexposure. A second safety feature can provide selective covering anduncovering of a second needle. The second needle can be configured forinsertion into a blood-collection receptacle. The second safety featurecan be configured to interact with and trigger an automatic deploymentof a permanent closure mode for the first needle. In some embodiments,the actuation of either or both of the first and second safety featuresis automatic or passive in that the user of the device can be engagingin other aspects of using the device when the safety features areinitiated by the device, thereby diminishing the risk of human error orneglect in deploying the safety features.

In some embodiments, a blood collection safety device has at least afirst mode and a second mode. The device can include a housingcomprising a chamber and a longitudinal axis. The device can alsoinclude a needle comprising a proximal tip and a distal tip, theproximal tip positioned in the chamber. The device can further include aplunger assembly configured to be received at least partly in thehousing, the plunger assembly comprising a first needle cover and asecond needle cover and a biasing member therebetween, the first needlecover and the second needle each configured to move along thelongitudinal axis. In some cases, in the first mode the first needlecover and the second needle cover are at least partly nested along thelongitudinal axis, and in the second mode the first needle cover and thesecond needle cover are spaced apart along the longitudinal axis. Insome embodiments, the device is configured to engage a blood collectionreceptacle, e.g., a vial. In certain embodiments, in the second mode aportion of the first needle cover is positioned distal of the distal tipof the needle. In certain configurations, the first needle cover furtherincludes an extension locking member.

In some embodiments, the first needle cover also has a rotationallocking member and the housing also has a cam member. In someconfigurations, in the first mode the first needle cover longitudinallyreceives at least part of the second needle cover.

In certain configurations, the second needle cover has a plurality oftracks, and the first needle cover has a guide member configured toslide along the plurality of tracks. In certain cases, at least one ofthe tracks is an angled track. The track can be angled with respect tothe longitudinal axis. In some cases, the sliding of the guide member inthe angled track rotates the second needle cover.

In some embodiments, the housing has a needle support, such as a beam,connected with the needle and the second needle cover has a channelconfigured to slidingly receive the needle support.

In some embodiments, a blood collection safety device includes a housingcomprising a chamber and a longitudinal axis. The device can also have aneedle comprising a proximal tip and a distal tip, the proximal tippositioned in the chamber. Further, the device can have a proximalneedle cover configured to move between an engaged position and adisengaged position. In some cases, the engaged position is at leastpartly distal of the disengaged position and the disengaged position isconfigured such that the proximal tip of the needle is positioned distalof a portion of the proximal needle cover. Additionally, the device caninclude a distal needle cover configured to move between a retractedposition and an extended position. In some arrangements, the distalneedle cover is positioned proximal of the distal tip of the needle inthe retracted position and the distal needle cover is positioned distalof the distal tip of the needle in the extended position. Someconfigurations of the device have a locking member configured to retainthe distal needle cover in the retracted position. In some cases, thelocking member is released by the proximal needle cover moving to theengaged position.

In some embodiments, the locking member has an axially extending arm. Incertain embodiments, the locking member is connected with a distalportion of the distal needle cover. In some configurations, the housingfurther includes a radially inwardly extending shoulder and a notch, andwherein the locking member engages the shoulder. In some embodiments,the locking member is released by rotation of the distal needle coverrelative to the housing. Certain configurations also include a reuseprevention member configured to inhibit proximal movement of the distalneedle cover after the distal needle cover has moved to the extendedposition.

In some embodiments, a method of manufacturing a blood collection safetydevice (such as a safety device having at least a first mode and asecond mode) includes providing a housing having a longitudinal axis anda needle. In certain embodiments, the method also includes providing afirst needle cover. Some configurations further include providing asecond needle cover, the second needle cover configured to engage ablood collection vial, the second needle cover at least partly nestedalong the longitudinal axis with the first needle cover in the firstmode. In some embodiments, the method also includes compressing abiasing member between the first needle cover and the second needlecover, the biasing member configured to encourage the first needle coverand the second needle cover to move to spaced apart positions along thelongitudinal axis in the second mode.

In some embodiments, in the second mode a portion of the first needlecover is positioned distal of the distal tip of the needle. In certainembodiments, the first needle cover also includes an extension lockingmember. In some configurations, the first needle cover has a rotationallocking member and the housing has a cam member. In some embodiments, inthe first mode the first needle cover longitudinally receives at leastpart of the second needle cover.

In some embodiments, the housing further includes a needle supportconnected with the needle. Furthermore, in certain arrangements, thesecond needle cover also has a channel configured to slidingly receivethe needle support.

In certain configurations, the second needle cover also includes aplurality of tracks, and the first needle cover also includes a guidemember configured to slide along the plurality of tracks. In some cases,at least one of the tracks is angled with respect to the longitudinalaxis. In some cases, the sliding of the guide member in the angled trackrotates the second needle cover.

According to some embodiments, a method of using a blood collectionsafety device, which has a distal needle cover, a proximal needle cover,and a needle, includes positioning a distal end of the needle near oradjacent to a patient (e.g., against the patient's skin). The method caninclude applying an amount of distally-directed force on the bloodcollection safety device such that the distal end of the needle piercesthe patient's skin. In certain implementations, the method includesengaging a blood collection vial with a proximal end of the needle,thereby placing the needle in fluid communication with the vial. Someembodiments include allowing blood to flow from the patient into thevial via the needle.

In certain variants, the method includes reducing the amount ofdistally-directed force such that the distal needle cover is moveddistally of the blood collection safety device. For example, the distalneedle cover can be moved by a biasing member. In some embodiments, themethod includes removing the distal end of the needle from the patient(e.g., from the patient's skin). Certain implementations includedisengaging the blood collection vial and the proximal end of theneedle.

In certain embodiments, the method includes forming at least some of aprotective enclosure around the needle. For example, in someembodiments, the protective enclosure is formed by positioning at leasta portion of the distal needle cover distal of the distal end of theneedle, thereby covering the distal end of the needle. In certainvariants, the protective enclosure is formed by positioning at least aportion of the proximal needle cover proximal of the proximal end of theneedle, thereby covering the proximal end of the needle. In someimplementations, the protective enclosure is formed by passivelysecuring the distal needle cover to prevent the distal end of the needlefrom moving distal of the portion of the distal needle cover. In someembodiments, the protective enclosure is formed by passively securingthe proximal needle cover to prevent the proximal end of the needle frommoving proximal of the portion of the proximal needle cover. Certainembodiments of the method include disposing of the blood collectionsafety device in a non-sharps waste receptacle.

In some embodiments, a method of using a blood collection safety device,which has a distal end, a proximal needle cover, and a needle, includesconnecting the distal end of the blood collection device with a medicalconnector that is configured to be in fluid communication with apatient's blood. For example, the distal end of the blood collectiondevice can include a medical connector interface. In some embodiments,the medical connector interface can comprise a male luer with aluer-lock shroud configured to be inserted into a corresponding femaleluer connector or another medical device, such as a catheter or shunt,connected to a patient. Many other structures and configurations can beused. For example, the medical connector interface can comprise a femaleluer connector configured to be attached to a male luer connector onanother medical device. In some embodiments, the medical connectorinterface is threaded, configured to accept a Luer connector, orotherwise shaped to attach directly to a medical device or otherinstruments. In certain variants, the medical connector interfaceincludes a passage or channel, such as a length of tubing. In someembodiments, the medical connector can be configured to engage with aneedleless IV access device.

In certain implementations, the method includes placing the needle influid communication with the medical connector. Some variants of themethod include engaging a blood collection vial with a proximal end ofthe needle, thereby placing the needle in fluid communication with thevial. In some embodiments, the method includes allowing blood to flowfrom the patient into the vial via the medical connector and the needle.

Certain implementations of the method include disengaging the bloodcollection vial and the proximal end of the needle. In some embodiments,the method includes forming at least some of a protective enclosurearound the needle. For example, certain implementations of the methodinclude positioning at least a portion of the proximal needle coverproximal of the proximal end of the needle, thereby covering theproximal end of the needle. Some implementations of the method includepassively securing the proximal needle cover to prevent the proximal endof the needle from moving proximal of the portion of the proximal needlecover. According to some embodiments, the method includes disposing ofthe blood collection safety device in a non-sharps waste receptacle.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the embodiments. In addition, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure.

FIG. 1A illustrates a perspective view of an embodiment of a bloodcollection safety device.

FIG. 1B illustrates a perspective view of the embodiment of FIG. 1A witha cap portion in a separated position.

FIG. 2A illustrates a perspective view of the blood collection safetydevice of FIG. 1A in an upright position and without the cap portion.

FIG. 2B illustrates an exploded perspective view of the embodiment ofFIG. 2A.

FIG. 3A illustrates a perspective view of an embodiment of a plungerassembly of the device of FIG. 1A.

FIG. 3B illustrates a perspective exploded view of the plunger assemblyof FIG. 3A.

FIG. 4A illustrates a bottom view of the device of FIG. 3A in an initialposition.

FIG. 4B illustrates a sectional view along the line 4B-4B of FIG. 4A.

FIG. 4C illustrates a sectional view along the line 4C-4C of FIG. 4B.

FIG. 5A illustrates a bottom view of the device of FIG. 3A in anextended and locked position.

FIG. 5B illustrates a sectional view along the line 5B-5B of FIG. 5A.

FIG. 5C illustrates a sectional view along the line 5C-5C of FIG. 5B.

FIG. 6A illustrates a perspective view of another embodiment of a bloodcollection safety device.

FIG. 6B illustrates a perspective exploded view of the device of FIG.6A.

FIG. 7A illustrates a bottom view of the device of FIG. 6A in an initialposition.

FIG. 7B illustrates a sectional view along the line 7B-7B of FIG. 7A.

FIG. 7C illustrates a sectional view along the line 7C-7C of FIG. 7B.

FIG. 8A illustrates a bottom view of the device of FIG. 6A in anextended and locked position.

FIG. 8B illustrates a sectional view along the line 8B-8B of FIG. 8A.

FIG. 8C illustrates a sectional view along the line 8C-8C of FIG. 8B.

FIG. 8D illustrates a focused view of a portion of FIG. 8B.

FIG. 9A illustrates a bottom view of another embodiment of a bloodcollection safety device.

FIG. 9B illustrates a sectional view along the line 9B-9B of FIG. 9A.

FIG. 10 illustrates a perspective view of another embodiment of a bloodcollection safety device, with a cap portion in a separated position.

FIG. 11 illustrates a perspective view of the device of FIG. 10 with alabel removed.

FIG. 12 illustrates a sectional view along the line 12-12 of FIG. 11.

FIG. 13 illustrates a perspective view of a plunger assembly for thedevice of FIG. 10.

FIG. 14 illustrates a bottom view of the plunger assembly of FIG. 13.

FIG. 15 illustrates a perspective view of another embodiment of a bloodcollection safety device having a housing, sheath, intermediate member,and piston.

FIG. 15A illustrates a perspective view of the device of FIG. 15 coupledwith a cap.

FIG. 15B illustrates a perspective view of the device of FIG. 15Acoupled with a sleeve.

FIG. 15C illustrates a perspective view of the device of FIG. 15B withthe cap removed.

FIG. 16 illustrates a perspective exploded view of the device of FIG.15, including the cap and the sleeve.

FIG. 17 illustrates a perspective view of an embodiment of the housingof the device of FIG. 15.

FIG. 17A illustrates a front view of the housing of FIG. 17.

FIG. 17B illustrates a top view of the housing of FIG. 17.

FIG. 17C illustrates a cross-sectional view along the line 17C-17C ofFIG. 17B.

FIG. 17D illustrates a cross-sectional view along the line 17D-17D ofFIG. 17B.

FIG. 18 illustrates a perspective view of an embodiment of the sheath ofthe device of FIG. 15.

FIG. 18A illustrates a front view of the sheath of FIG. 18.

FIG. 18B illustrates a top view of the sheath of FIG. 18.

FIG. 19 illustrates a perspective view of an embodiment of theintermediate member of the device of FIG. 15.

FIG. 19A illustrates a rear perspective view of the intermediate memberof FIG. 19.

FIG. 19B illustrates a front view of the intermediate member of FIG. 19.

FIG. 19C illustrates a cross-sectional view along the line 19C-19C ofFIG. 19B.

FIG. 19D illustrates a top view of the intermediate member of theintermediate member of FIG. 19.

FIG. 20 illustrates a perspective view of an embodiment of the piston ofthe device of FIG. 15.

FIG. 20A illustrates a front view of the piston of FIG. 20.

FIG. 20B illustrates a cross-sectional view along the line 20B-20B ofFIG. 20A.

FIG. 21 illustrates a perspective view of an embodiment of the sleeve ofthe device of FIG. 15B.

FIG. 21A illustrates a bottom view of the sleeve of FIG. 21.

FIG. 22 illustrates a front view of the device of FIG. 15 in an initialstate.

FIG. 22A illustrates a rear perspective partial cross-sectional view ofthe device of FIG. 22.

FIG. 22B illustrates a cross-sectional view along the line 22B-22B ofFIG. 22.

FIG. 23 illustrates a front view of the device of FIG. 15 in aready-to-operate state.

FIG. 23A illustrates a rear perspective partial cross-sectional view ofthe device of FIG. 23, with the sleeve and biasing member notillustrated for clarity.

FIG. 23B illustrates a top view of the device of FIG. 23.

FIG. 23C illustrates a cross-sectional view along the line 23C-23C ofFIG. 23A.

FIG. 23D illustrates a cross-sectional view along the line 23D-23D ofFIG. 23A.

FIG. 24 illustrates a front view of the device of FIG. 15 in anintermediate state, with the sleeve and biasing member not illustratedfor clarity.

FIG. 24A illustrates a rear perspective partial cross-sectional view ofthe device of FIG. 24.

FIG. 24B illustrates a top view of the device of FIG. 24.

FIG. 24C illustrates a cross-sectional view along the line 24C-24C ofFIG. 24B.

FIG. 25 illustrates a front view of the device of FIG. 15 with thesheath in a distal and locked position.

FIG. 25A illustrates a rear perspective partial cross-sectional view ofthe device of FIG. 25, with the sleeve and biasing member notillustrated for clarity.

FIG. 25B illustrates a front perspective partial cross-sectional view ofthe device of FIG. 25, with the sleeve and biasing member notillustrated for clarity.

FIG. 26 illustrates a front view of the device of FIG. 15 in a lockedstate.

FIG. 26A illustrates a rear perspective partial cross-sectional view ofthe device of FIG. 26, with the sleeve and biasing member notillustrated for clarity.

FIG. 26B illustrates a top view of the device of FIG. 26.

FIG. 26C illustrates a cross-sectional view along the line 26C-26C ofFIG. 26.

FIG. 26D illustrates a cross-sectional view along the line 26D-26D ofFIG. 26.

FIG. 27 illustrates a schematic disposal diagram of certain componentsof the device of FIG. 15.

FIG. 28 illustrates a perspective view of another embodiment of a bloodcollection safety device having a housing, intermediate member, andpiston.

FIG. 28A illustrates a perspective view of the device of FIG. 28 coupledwith a sleeve.

FIG. 29 illustrates a perspective exploded view of the device of FIG.28A.

FIG. 30 illustrates a perspective view of an embodiment of the housingof the device of FIG. 28.

FIG. 30A illustrates another perspective view of the housing of FIG. 30.

FIG. 31 illustrates a perspective view of an embodiment of theintermediate member of the device of FIG. 28.

FIG. 31A illustrates a rear view of the intermediate member of FIG. 31.

FIG. 32 illustrates a perspective view of an embodiment of the piston ofthe device of FIG. 28.

FIG. 33 illustrates a perspective view of the device of FIG. 28 in aninitial state.

FIG. 34 illustrates a cross-sectional perspective view of the device ofFIG. 33 in a ready-to-operate state.

FIG. 35 illustrates a cross-sectional perspective view of the device ofFIG. 33 during a blood collection portion of a blood collectionprocedure.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

A variety of examples of blood collection safety devices are describedbelow to illustrate various examples that may be employed to achieve oneor more desired improvements. These examples are only illustrative andnot intended in any way to restrict the general inventions presented andthe various aspects and features of these inventions. For example,although embodiments and examples are provided herein in the medicalfield, the inventions are not confined exclusively to the medical fieldand certain embodiments can be used in other fields. Furthermore, thephraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. No feature,structure, or step disclosed herein is essential or indispensible.

As illustrated in FIG. 1, in some embodiments, a blood collection safetydevice 100 includes a needle 102, housing 104, plunger assembly 105, asleeve 106, and a longitudinal axis L. The needle 102 can include adistal end 117 and a proximal end 119 (FIG. 2B). As used herein, theterm “distal,” or any derivative thereof, refers to a direction towardthe end of the blood collection safety device 100 that penetrates apatient's body; the term “proximal” refers to the opposite direction andis normally in the direction toward a user holding the blood collectionsafety device 100. Many kinds of medical needle (including needles fordentistry or veterinary procedures) can be used. Furthermore, althoughthe needle 102 illustrated comprises a generally unitary tube, in otherembodiments, the needle 102 comprises two distinct needle portions. Insome embodiments, the two distinct needle portions extend in generallyopposite directions. In some implementations, the two distinct needleportions are longitudinally spaced apart and are in fluid communication.

The blood collection safety device 100 can include features andcomponents that automatically inhibit, prevent, or otherwise discourageusing the device 100 multiple times or inadvertently inserting theneedle into a second person, such as a health care professional oranother patient. As used herein, the terms “automatically,” “automatic,”“passive,” and “passively,” and similar terms, are intended to havetheir ordinary meanings in the field. In some embodiments, as thecontext reflects, these terms refer to a mechanism or process thatoccurs in normal usage of a product and/or that occurs while the user isperforming another process, without requiring an additional step ormanipulation by the user (e.g., pressing a button, pushing a lever,triggering a switch, or otherwise) to achieve the desired result. Forexample, certain embodiments of the blood collection safety device 100include a locking system that automatically or passively inhibits accessto the distal end 117 of the needle 102 after a single use of the bloodcollection safety device 100. Such embodiments can, for example, reducethe likelihood of transferring blood or tissue-born diseases from onepatient to another. The locking system and/or reuse-inhibition featuresof the blood collection safety device 100 could be used with manydifferent types of medical and non-medical products.

Certain embodiments of the blood collection safety device 100 caninclude features and components that generally cover, obscure, extendbeyond, protect, or hide at least the distal end 117 of the needle 102after a single use of the blood collection safety device 100. In someembodiments, such configurations can, for example, reduce the likelihoodof accidental contact with the distal end of the needle 117, e.g.,unintentional needle sticks. Further, such configurations can reduce oralleviate at least some anxiety or fear that might otherwise be felt bycertain patients or other individuals upon seeing the sharp distal end117 being removed from their body. In some embodiments, both the distalend 117 and the proximal end 119 are covered, obscured, hidden, orprotected by the blood collection safety device 100. Further detailsregarding some example embodiments of medical devices with automaticallycovering features that can be used with the devices disclosed herein areprovided in U.S. Pat. No. 7,811,261, issued Oct. 12, 2010, and U.S.Patent Application Publication No. 2011/0319817, filed Jun. 23, 2010,each of which is incorporated herein by reference in its entirety.

In certain arrangements, a cap 101 is configured to mate with thehousing 104 and/or cover the distal end 117 of the needle 102. In someinstances, the cap 101 can include a distally extending casing that isclosed at one end and configured to receive a portion of the needle 102at the other end. The cap 101 can reduce or prevent contamination of theneedle 102, for example during shipping and storage of the bloodcollection safety device 100. The cap 102 is generally removed justprior to a blood collection procedure, at which time the cap can bediscarded. In certain embodiments, the cap is connected with the housing104 by a hinge element, thereby allowing the cap 102 to be moved toexpose the distal end 117 of the needle 102 yet remain connected withthe housing 104. Such a configuration can, for example, provide forfewer discrete pieces for the user to monitor and keep track of.

As shown in FIG. 2B, the sleeve 106 can include a proximal end 131, adistal end 132, and an internal chamber 133. In certain configurations,the proximal end 131 includes projections 134, which can facilitategripping or holding the blood collection safety device 100. As shown,the distal end 132 can include a distal opening 135, which can beconfigured to receive a portion of the housing 104. In some cases, thedistal end 132 has threads 123. The chamber 133 is normally configuredto receive a blood collection vial, such as a Vacutainer® bloodcollection vial or the like. The proximal end 131 of the sleeve 106 caninclude a proximal aperture 136 (FIG. 4A) to allow the blood collectionvessel to be received into the chamber 133. In certain embodiments, thehousing 104 and the sleeve 106 are monolithically formed.

The housing 104 can include a proximal body portion 141, a distal bodyportion 142, an outer surface 143, and an inner surface 144. In somecases, the needle 102 mounts with the housing 104, such as with anadhesive, sonic welding, or otherwise. In some embodiments, the housing104 includes a needle support 181 (FIG. 4A), such as a beam, configuredto maintain the needle 102 in a position generally along thelongitudinal axis L. In some cases, the proximal end 119 of the needle102 is positioned inside and covered with a resilient boot 120.

The proximal body portion 141 can be configured to couple with thehousing 104. For example, in the embodiment shown in FIG. 2A, theproximal body portion 141 of the housing 104 is received by the distalend 132 of the sleeve 106. In certain cases, the outer surface 143 ofthe housing 104 includes threads 127 which can be configured to matewith the threads 123 of the sleeve 106. Also, in certain cases, theouter surface 143 of the housing 104 has a radially outwardly extendingflange 145 which can, for example, limit the amount of insertion of thehousing 104 into the sleeve 106.

As illustrated, the distal body portion 142 can have a radially inwardlyextending shoulder 146 and a distal aperture 147. In some cases, thedistal body portion 142 also includes one or more distally extendingguides 148. Such guides can include a bearing surface 126 (FIG. 4B) andcan, for example, provide radial support during movement of the plungerassembly 105, as will be discussed below. In certain configurations, theshoulder 146 includes one or more radial notches 149. As shown, thenotches 149 can be positioned between the guides 148.

In certain embodiments, the distal body portion 142 includes one or moreretraction locking members 150. In some cases, the retraction lockingmember 150 is positioned at least partially within a window 153 includedin the distal body portion 142. As shown, a first end 151 of theretraction locking member 150 can be coupled with the distal bodyportion 142, while a second end 152 of the retraction locking member 150can be disposed radially inwardly. In some embodiments, the retractionlocking member 150 is generally resilient, so that the radially inwardlydisposed second end 152 can flex and then return to its originalposition after the second end 152 has been radially outwardly deflected.In some embodiments, the first end 151 is larger than the second end152, e.g. the retraction locking member 150 can taper from the first end151 to the second end 152. In some embodiments, the retraction lockingmember 150 includes a latching member, such as a hook, clasp, detent,ratchet, or otherwise.

With continued reference to FIG. 2B, as well as to FIGS. 3A and 3B, theplunger assembly 105 can include a sheath 107, a biasing member 108, anda piston 109. In various embodiments, at least part of the plungerassembly 105 is configured to be received in the housing 104 and in thesleeve 106.

The sheath 107 can have an elongate shape having a central lumentherethrough, a proximal end 161, and a distal end 162 with a distalaperture 180. In some cases, the sheath 107 includes a distallyextending portion 163 configured to receive the biasing member 108. Thedistally extending portion 163 can have most any shape, such as annular,cylindrical, frustoconical, or otherwise. In certain cases, the sheath107 has at least one radially inwardly extending guide member 111, whichcan be configured to mate with one or more portions of the piston 109,as discussed below. The central lumen and the distal aperture 180 can beconfigured to receive the distal end 117 of the needle 102 therethrough.

In some configurations, the sheath 107 has one or more extension lockingmembers 118. For example, as shown, the sheath 107 includes a radiallyoutwardly extending extension locking member 118. In certainconfigurations, the extension locking member 118 is sized to be receivedthrough the notch 149 along the longitudinal axis, as discussed below.In some embodiments, the extension locking member 118 is disposed in awindow 164 of the sheath 107. In some cases, the window 164 opens intothe central lumen of the sheath 107. In some configurations, theextension locking member 118 is substantially anchored to the sheath107. For instance, in some cases the locking member 118 includes aradially projecting fin. In other configurations, only a portion of theextension locking member 118 is anchored to the sheath 107. For example,a first end 165 of the extension locking members 118 can be connectedwith the sheath 107 and a second end 166 of the extension lockingmembers 118 a can be angled radially outwardly.

In some embodiments, the extension locking member 118 is generallyresilient. A resilient extension locking member 118 can allow theradially outwardly disposed second end 166 to flex and then return toits original position after the second end 166 has been radiallyinwardly deflected. In some embodiments, the first end 165 is largerthan the second end 166, e.g., the extension locking member 118 cantaper from the first end 165 to the second end 166. In some embodiments,the extension locking member 118 includes a latching member, such as ahook, clasp, detent, ratchet, or otherwise.

In certain configurations, the sheath 107 has one or more rotationallocking members 116. For example, in certain embodiments the sheath 107includes two rotational locking members 116, equally spaced about theperiphery of the sheath 107. As shown in FIG. 3B, the rotational lockingmembers 116 can be located near the proximal end 161 of the sheath 107.However, in other configurations, the rotational locking members 116 arepositioned in other locations, such as near the distal end 162 of thesheath 107.

The rotational locking member 116 can include a projection that extendscircumferentially, radially, axially, or a combination thereof. Forexample, in the embodiment of FIG. 3B, the rotational locking member 116projects radially outward from, and along a portion of the circumferenceof, the sheath 107. The rotational locking member 116 can be generallyresilient, to allow the rotational locking member 116 to return to itsoriginal position after having been deflected radially inwardly. In someaspects, the rotational locking member 116 also includes an intermediatenarrowed portion 168, which can facilitate such flexing of therotational locking member 116.

In certain configurations, the rotational locking member 116 a has acantilevered end 167. In some cases, the cantilevered end 167 istapered, such that the radial width of the cantilevered end 167decreases. In some cases, the cantilevered end 167 includes a radiallyoutwardly extending wedge, such that the radial width of thecantilevered end 167 increases. In certain aspects, the cantilevered end167 is flat.

Some embodiments of the sheath 107 include one or more grooves 169. Forexample, as shown in FIG. 3B, the sheath 107 includes a groove 169 thatextends substantially longitudinally. In some embodiments, such a groove169 is configured to mate with a corresponding projection in the housing104 or piston 109 to guide the longitudinal movement of the sheath 107.In some configurations, the groove 169 extends substantially the entirelength of the sheath 107. In other configurations, the groove 169extends along only a portion of the length of the sheath 107. In somecases, the groove 169 extends circumferentially or helically along aportion of the sheath 107.

In some embodiments, such as in the illustrated embodiment, the biasingmember 108 engages and extends between the sheath 107 and the piston109. The biasing member 108 illustrated is a conical spring, but manytypes of biasing member 108 can be employed, such as a helical spring,wave-spring, belleville washers, or otherwise. In some embodiments, thebiasing member 108 is a conical coil spring having a free length ofabout 100 mm and a spring rate of at least about 0.12 N/mm through thelinear portion of the spring's deflection. Other constructions caninclude softer or stiffer springs depending on the application, and canbe constructed of substantially any suitable material. Progressivesprings and/or multiple springs of varying lengths can also be used, forexample, to provide a variable effective spring rate.

In some configurations, the biasing member 108 is configured tofacilitate extension of the sheath 107 after a blood collection vial hasbeen engaged with the blood collection safety device 100. Further, thebiasing member 108 can be configured to facilitate movement of thesheath 107 distally without distal force by the user. For example, whenthe user is moving the blood collection safety device 100 proximally(such as during extraction of the distal end 117 of the needle 102 froma patient's body), the biasing member 108 can be configured to encouragethe sheath 107 distally relative to the housing 104.

In certain embodiments, the piston 109 has a generally elongate body 170and a proximal flange 171. The elongate body 170 can include a centrallumen extending the length of the piston 109 and configured to allowpassage of the proximal end 119 of the needle 102 therethrough. Theproximal flange 171 can include a radially outwardly extending proximalsurface 172, which can be configured to mate with the distal end of ablood collection vial. As shown in FIG. 3B, the piston 109 can include alongitudinally extending channel 173. In some cases, the channel 173does not extend the entire longitudinal length of the piston 109.Accordingly, in certain configurations, the channel 173 terminates in astop 174. In some cases, the piston 109 includes a distally extendingportion 175 which can receive the biasing member 108.

With continued reference to FIGS. 3A and 3B, the piston 109 can includean initial track 113, a transfer track 114, and an engagement track 115to aid in, for example, directing movement of the sheath 107. As shown,the tracks 113-115 can be located on an external surface of the piston109. However, other track locations are contemplated, such as on theinside of the sheath 107 or on the inside of the housing 104. In manyarrangements, the tracks are configured to slidingly receive the guidemember 111 of the sheath 107. Accordingly, the tracks 113-115 can beconfigured to have a similar cross-sectional shape as the guide member111, e.g., generally rectangular, generally T-shaped, generally circularsector, or otherwise. For instance, the illustrated guide member 111 andthe tracks 113-115 are generally trapezoidal in cross sectional shape.

In some embodiments, the initial track 113 and the engagement track 115are generally parallel to the longitudinal axis. In some cases, theinitial track 113 extends along only a portion of the longitudinallength of the piston 109 and the engagement track 115 extends alongsubstantially all of the longitudinal length of the piston 109. Forexample, in some cases, the initial track 113 extends along at leastabout 20% of the longitudinal length of the piston 109 and theengagement track 115 extends along at least about 90% of the length ofthe piston 109. In some configurations, a separation member 176separates the initial and engagement tracks 113, 115 throughout at leasta portion of their length.

The transfer track 114 can be positioned in a middle or intermediateregion along the length of the piston 109 and at an angle relative tothe longitudinal axis (e.g., non-parallel to the axis), and canintersect the initial and engagement tracks 113, 115. The transfer track114 can thus connect the initial and engagement tracks 113, 115 topermit the guide member 111 to shift between the initial track 113 andthe engagement track 115 as will be discussed in further detail below.In some embodiments, the transfer track 114 is generally straight andnon-curvilinear to facilitate smooth travel along the transfer track114. In the example illustrated, the intersection of the transfer track114 and the engagement track is positioned in about the longitudinalmiddle of the piston 109. In some embodiments, the intersection of thetransfer track 114 and the initial track 113 is distal to theintersection of the transfer track 114 and the engagement track 115. Insome embodiments, the length of the transfer track 114 is generallysubstantially less than the longitudinal length of the piston 109. Inthe illustrated embodiment, the transfer track 114 does not constitute aportion of, or a continuation of, either of the initial or engagementtracks 113, 115; rather, the transfer track 114 extends away from thetracks 113, 115 at a point on each track 113, 115 that is spaced betweenthe beginning and end of the tracks 113, 115 (e.g., at an intermediateor middle region of the tracks 113, 115). In certain embodiments, theengagement track 115 terminates in a distal open notch 178.

In some embodiments, the piston 109 includes an assembly track 177. Theassembly track 177 can be configured to be inclined in the directionfrom the engagement track 115 toward the initial track 113 and terminatein a generally flat face 179 at the intersection between the initialtrack 113 and the assembly track 177. Such a track 177 can facilitate,for example, assembly of the guide member 111 into the initial track113. For example, during assembly of come embodiments of the bloodcollection safety device 100, the guide member 111 of the sheath 107 isinserted through the distal open notch 178 of the engagement track 115and then into the assembly track 177. As the guide member 111 is movedalong the assembly track 177 the guide member 111 rides up the inclineof the assembly track 177 until reaching the generally flat face 179, atwhich point the guide member 111 can snap to the bottom of the initialtrack 113. Thereafter, the flat face 179 can inhibit or preventdisassembly of the sheath 107 from the piston 109 by presenting abarrier or impediment to the guide member 111 returning along theassembly track 177.

The blood collection safety device 100 can have many different sizes, toaccommodate the various sizes of blood collection vials and types ofblood collection procedures. In some embodiments, the blood collectionsafety device 100 can have an overall length of at least about 25 mmand/or less than or equal to about 200 mm, a sleeve 106 with an outsidediameter of at least about 6 mm and/or less than or equal to about 50mm, a housing 104 with an outside diameter of at least about 5 mm and/orless than or equal to about 45 mm and a sheath 107 with an outsidediameter of at least about 3 mm and/or less than or equal to about 20mm. In some embodiments, the sheath 107 is longitudinally longer thanthe piston 109. In some embodiments, the sheath 107 is longer than thehousing 104 (not including the needle 102). In some embodiments, theneedle 102 has a gauge of at least 15 (nominal outside diameter of about1.83 mm) and/or less than or equal to 34 (nominal outside diameter ofabout 0.18 mm).

The blood collection safety device 100, and components thereof, can beformed using many manufacturing processes sufficient to provide thedesired shape of the components. In some embodiments, one or morecomponents are made by a molding process, such as, injection molding,compression molding, blow molding, transfer molding, or similar. In someembodiments, one or more components are formed by forging, machining,casting, stamping, extrusion, a combination thereof, or otherwise.

In many embodiments, the blood collection safety device 100 isconstructed from a generally non-corroding, bio-stable material. Forexample, in some arrangements, one or more of the components of theblood collection safety device 100 are plastic (e.g.,polyetheretherketone) or metal (e.g., aluminum, titanium, stainlesssteel, or otherwise). In some embodiments, the sleeve 106, housing 104,and/or the sheath 107 are constructed of materials that are translucent,opaque, or otherwise optically distortive, such that some portion (e.g.,the distal tip 117) or all of the needle 102 is generally covered afterthe blood collection procedure has been completed and the needle 102 hasbeen removed from the patient.

With reference to FIG. 4A, which illustrates a bottom view of the bloodcollection safety device 100, the housing 104 can further include theneedle support 181 and an inner chamber 184. In certain cases, theneedle support 181 extends from one side of the housing 104 to the otherside thereof. For example, as shown, the needle support 181 can extenddiametrically across the diameter of the housing 104. The needle support181 can connect with the needle 102, such as by an adhesive. In certainembodiments in which the needle 102 comprises two distinct needleportions, the two distinct needle portions are mounted to the needlesupport 181.

In some cases, the inner surface 144 of the housing 104 includes aradially inwardly extending rib 125. Such a rib 125 can, for example,provide support for, and inhibit kinking of, the plunger assembly 105during movement of the sheath 107. In some cases, the rib 125 extendsradially inward but does not inhibit longitudinal movement of the sheath107. The rib 125 can extend along a portion or substantially all of thelongitudinal length of the housing 104.

In certain configurations, the housing 104 includes a generallywedge-shaped cam member 124 that extends radially inwardly from theinner surface 144 of the housing 104. The cam member 124 can include agenerally flat face 182 and an inclined face 183. In the variant shown,the inclined face 183 is configured to be in the circumferentiallyopposite direction as the flat face 184. The cam member 124 can extendalong a portion or substantially all of the longitudinal length of thehousing 104.

As shown in FIG. 4C, in the rotational locking members 111 of the sheath107 can be circumferentially disposed between the rib 125 and theinclined face 183 of the cam member 124. In certain configurations, thecantilevered end 167 of the rotational locking member 111 points awayfrom the inclined face 183 of the cam member 124.

In FIGS. 4A-4C, the blood collection safety device 100 is illustrated inan initial and ready-to-operate mode. The plunger assembly 105 isreceived in the housing 104, which in turn is mated with the sleeve 106.The sheath 107 is in a first position, which exposes the distal end 117a of the needle 102 a, and the piston 109 is covering the proximal end119 of the needle 102. The needle support 181 of the housing 104 isreceived in the channel 173 of the piston 109 and is abutted with thestop 174. The extension locking member 118 of the sheath 107 is receivedin the inner chamber 184 of the housing 104 and, as shown in thisinitial position, abuts against the radially inwardly extending shoulder146 of the housing 104. Accordingly, although the bias of the biasingmember 108 tends to drive the plunger 109 and the sheath 107 apart, theneedle support 181 abutting the stop 174 inhibits proximal movement ofthe piston 109 and the shoulder 146 abutting the extension lockingmember 118 inhibits distal movement of the sheath 107. Thus, in thisinitial and ready-to-operate configuration, the sheath 107 and thepiston 109 are held in a stable first position relative to each other.In certain embodiments, in the first position of the sheath 107 and thepiston 109, the sheath 107 receives at least some of the longitudinallength of the piston 109. For example, as shown a portion of the piston109 can be received into the central lumen of the sheath 107.Furthermore, as shown in FIG. 3A, in the initial and ready-to-operatemode the guide member 111 of the sheath 107 is disposed in the initialtrack 113 of the piston 109.

During a blood collection procedure, after removing the cap 101 (ifused) and taking surface prepatory steps (if appropriate, e.g. applyinga disinfectant to the surface), the distal end 117 of the needle 102 canbe placed against the patient's skin at the desired penetration site.

After the distal end 117 of the 102 is inserted into the patient, e.g.,in a vein, the blood collection portion of the procedure generallybegins. A distal end a blood collection vial (not shown) can be abuttedwith the proximal surface 172 of the piston 109. The user generallyapplies distal force to the blood collection vial, which in turn appliesdistal force to the piston 109 against the bias of the biasing member108 (which, in certain embodiments, has been biasing the piston 109proximally into abutment with the stop 174). The distal force on thepiston 109, if sufficiently large, can overcome the bias of the biasingmember 108 and move the piston 109 distally, which can expose theproximal end 119 of the needle 102 and allow engagement of the bloodcollection vial with the proximal end 119 of the needle 102.

In certain configurations, as the piston 109 moves distally, the guidemember 111 of the sheath 107 slides along the initial track 113 untilthe guide member 111 reaches the intersection of the initial track 113and the transfer track 114. Upon reaching the intersection of theinitial and transfer tracks 113, 114, further distal movement of thepiston 109 encourages the guide member 111 into the angled transfertrack 114.

As the blood collection vial is continued to be moved distally, therebymoving the piston 109 further distally, the guide member 111 traversesthe transfer track 114 thereby encouraging the sheath 107 to rotateabout the longitudinal axis by approximately the number of degrees(e.g., at least about 10° and/or less than or equal to about 120°) thatseparate the initial and engagement tracks 113, 115. In contrast,rotation of the piston 109 (relative to the housing 104) can beinhibited by the needle support 181 passing through the channel 173 ofthe piston 109.

Rotation of the sheath 107 in turn rotates the rotational locking member116. In certain embodiments, the rotational locking member 116 rotatestoward the inclined face 183 of the cam member 124. Continued rotationof the rotational locking member 116 of the sheath 107 slidably engagesthe rotational locking member 116 (e.g., the cantilevered end 167) withthe inclined face 183, thereby deflecting the rotational locking member116 radially inward and producing a slight but noticeable resistance. Insome embodiments, as illustrated, the circumferential length of therotational locking member 116 can be generally about the same as orshorter than the length of the transfer track 114.

With further distal movement of the blood collection vial, and in turnthe piston 109, the guide member 111 exits from the transfer track 114into the engagement track 115, thus continuing to rotate the sheath 107with respect to the piston 109. Such continued rotation can rotate therotational locking member 116 beyond the circumferential width of thecam member 124, thereby allowing the rotational locking member 116 todeflect radially outward to about its original radial position shown inFIG. 4C. In this configuration, the generally flat face 182 presents aphysical stop thereby inhibiting counter-rotation of the rotationallocking member 116, and in turn the sheath 107. As the sheath 107 isinhibited from counter-rotating, the guide member 111 is inhibited fromreturning into the transfer track 114. In some embodiments, the outwarddeflection of the rotational locking member 116 produces a tactilevibration and/or an audible sound, e.g. “snap,” which can provideverification that the rotational locking member 116 has been locked andcounter-rotation is prevented.

In certain configurations, rotation of the sheath 107 can rotate theextension locking member 118 into longitudinal alignment with the notch149 in the shoulder 146 of the housing 104. For example, about when theguide member 111 of the sheath 107 enters the engagement track 115, theextension locking member 118 rotates into longitudinal alignment withthe notch 149. In some cases, about when the rotational locking member116 of the sheath 107 rotates past the cam member 124, the extensionlocking member 118 rotates into longitudinal alignment with the notch149.

In some embodiments, when the extension locking member 118 is alignedwith the notch 149, the extension locking member 118 no longer abuts theshoulder 146. Rather, in such embodiments, the extension locking member118 is allowed to pass distally through the notch 149. Accordingly, whenthe extension locking member 118 aligned with the notch 149, the sheath107 can be moved distally by the bias of the biasing member 108. In somesuch cases, the sheath 107 moves distally into abutment with the surfacebeing penetrated by the needle 102 (e.g., the skin of the patient).

In various embodiments, if additional samples of blood are desired,additional blood collection vials can be engaged with the proximal end119 of the needle 102. Once the desired number of samples has beencollected, the user generally moves the blood collection safety device100 proximally, thereby extracting the distal end 117 of the needle 102from the patient. In some embodiments, as the distal end 117 of theneedle 102 is extracted proximally, the sheath 107 is automaticallymoved distally (relative to the distal end 117) by the bias of thebiasing member 108. As the biasing member 108 can automatically move thesheath 107, the user does not need to remember to trigger or otherwiseactivate such a feature.

In certain configurations, after the distal end 117 of the needle 102 isremoved from the patient, the sheath 107 covers the distal end 117. Suchconfigurations can reduce the likelihood of accidental contact with thedistal end of the needle 117, e.g., unintentional needle sticks. Forexample, a portion of the sheath 107 can be moved to a position distalof the distal end 117 of the needle 102. In some cases, the sheath 107is moved such that the distal aperture 180 is distal of the distal end117.

In some embodiments, rotation of the sheath 107 can rotate therotational locking member 116 into longitudinal alignment with theretraction locking member 150 in the housing 104. For example, incertain cases, about when the guide member 111 of the sheath 107 entersthe engagement track 115, the rotational locking member 116 rotates intolongitudinal alignment with the retraction locking member 150. In somecases, when the rotational locking member 116 rotates past the cammember 124, it also rotates into longitudinal alignment with theretraction locking member 150.

In some configurations, as the sheath 107 is moved distally by thebiasing member, the rotational locking member 116 of the sheath 107engages the retraction locking member 150. For example, in some cases,the rotational locking member 116 directly contacts the retractionlocking member 150. In some cases, the rotational locking member 116 candeflect the retraction locking member 150 radially outwardly. As thesheath 107 continues to move distally, the rotational locking member 116can continue to increase the outward deflection of the retractionlocking member 150.

With regard to FIGS. 5A-C, the blood collection safety device 100 isillustrated in an extended and locked position. In the embodiment shown,the rotational locking member 116 has moved distal of the retractionlocking member 150 and into abutment with the shoulder 146. As therotational locking member 116 is no longer deflecting the retractionlocking members 150, the retraction locking members 150 have deflectedradially inward again (e.g., to about their original position). In sucha configuration, the retraction locking member 150 presents aninterference that inhibits proximal movement of the rotational lockingmember 116. Thus, proximal movement of the sheath 107 is inhibited bythe retraction locking member 150 and distal movement of the sheath 107is inhibited by the shoulder 146, thereby rendering the sheathsubstantially locked and/or immobile. Further, as the sheath 107 can beconfigured to extend distal of the distal end of the needle 102, thelocked sheath 107 renders the needle 102 generally inaccessible. Such aconfiguration can discourage or prevent re-use of the needle 102 and canreduce the chance of or substantially prevent unintentional contact withthe needle 102.

FIGS. 6A-8D illustrate another embodiment of a blood collection safetydevice 100 a. Several features and components of the blood collectionsafety device 100 a are identical or similar in form and function tothose described above with respect to the blood collection safety device100, and have been provided with like numerals, with the addition of “a”(e.g., 100 a rather than 100). To the extent that parts of the bloodcollection safety device 100 a differ from those of the blood collectionsafety device described above, some of those differences are describedand explained herein. Any features and/or components of the disclosedembodiments can be combined or used interchangeably.

In the embodiment illustrated in FIGS. 6A and 6B, the blood collectionsafety device 100 a includes a needle 102 a, sleeve 106 a, plungerassembly 105 a, and housing 104 a, and a longitudinal axis La. Theneedle can include a distal end 117 a and a proximal end 119 a. In somecases, a resilient boot 120 a covers the proximal end 119 a of theneedle 102 a. In certain arrangements, a removable cap 101 a isconfigured to mate with the housing 104 a and/or cover the needle 102 a.As discussed in further detail below, the blood collection safety device100 a can be configured to protect and cover the distal and proximalends 117 a, 119 a of the needle 102 a after the distal end 117 a hasbeen removed from a patient. Such a configuration can reduce thelikelihood of unintentional contact with distal end 117 a as well aswith the proximal end 119 a.

In certain embodiments, the housing 104 a can include a proximal bodyportion 141 a, a distal body portion 142 a, and an inner chamber 184 a.The proximal body portion 141 a can be received into and engage with adistal end 132 a of the sleeve 106 a. The distal body portion 142 a canhave a radially inwardly extending shoulder 146 a and a distal aperture147 a, which can be configured to receive the plunger assembly 105 a.For example, as shown, the distal aperture 147 a can include notches 149a, which can be configured to accept corresponding portions of theplunger assembly 105 a. Some embodiments of the housing 104 a alsoinclude a needle support 181 a (FIG. 7A), which can connect with theneedle 102 a and maintain the needle 102 a substantially along thelongitudinal axis.

In some embodiments, the plunger assembly 105 a includes a sheath 107 a,a biasing member 108 a, and a piston 109 a. In various embodiments, atleast part of the plunger assembly 105 a is configured to be received inthe housing 104 a and in the sleeve 106 a.

Certain configurations of the sheath 107 a have an elongate shape with acentral lumen therethrough, a proximal end 161 a, and a distal end 162 awith a distal aperture 180 a. The sheath 107 a can also have a flange185 a, which can seat against the biasing member 108 a. For example, theflange 185 a can extend radially outward. In some cases, the flange 185a is continuous, e.g., an annular ring. In other cases, the flange 185 ais discontinuous, e.g., one or more discrete radial projections. Asshown in FIG. 7C, the sheath 109 a can include a guide member 111 a. Insome cases, the guide member 111 a extends radially inwardly. In someembodiments, the sheath 107 a has an extension locking member 118 a. Insome configurations, the sheath 107 a includes a retraction lockingmember 150 a.

As shown in FIG. 7B, the proximal end 161 a can be configured to bereceived in the piston 109 a. In some embodiments, the proximal end 161a includes one or more biased fingers 186 a. For example, the fingerscan be biased radially outward. However, in certain states of certainembodiments, such as is illustrated in FIG. 7B, the biased fingers 186 acan be deflected radially inward within the piston 109 a.

Some embodiments of the proximal end 161 a have a locking tooth 189 a.As shown in FIG. 8D, the locking tooth 189 a can extend radiallyoutward. The locking tooth 189 a can be configured to abut with ashoulder 190 a of the piston 109 a. Thus, in certain embodiments, thelocking tooth 189 a can inhibit distal removal of the sheath 107 a fromthe piston 109 a.

The piston 109 a can include a generally elongate body 170 a and aproximal flange 171 a. The elongate body 170 a can include a centrallumen extending the length of the piston 109 a, which is configured toallow passage of the distal end 117 a of the needle 102 a therethrough.In some embodiments, the elongate body 170 a has radially extendingwings 187 a. In some configurations, the radially extending wings 187 aextend substantially transverse to the locking tooth 189 a. In certainconfigurations, the radially extending wings 187 a terminate in a seat188 a for the biasing member 108 a.

In some embodiments, the proximal flange 171 a includes a radiallyinwardly extending proximal surface 172 a, which can be configured toabut with the distal end of a blood collection vial. As shown in FIG.6B, the piston 109 a can include a longitudinally extending channel 173a that terminates in a stop 174 a. The channel 173 a can be configuredto receive a portion of the needle support 181 a of the housing 104 a.

In some embodiments, the piston 109 a has tracks similar to the tracks113-115 of the piston 109 of the blood collection safety device 100. Forexample, the piston 109 a can include an initial track 113 a, a transfertrack 114 a, and an engagement track 115 a. In some arrangements, thetracks 113 a-115 a are located on an external surface of the piston 109a. The tracks 113 a-115 a can be configured to slidingly receive theguide member 111 a of the sheath 107 a and can have a similarcross-sectional shape as the guide member 111 a.

With reference to FIGS. 7A-7C, the blood collection safety device 100 ais illustrated in an initial and ready-to-operate mode. The plungerassembly 105 a is received in the housing 104 a, which in turn is matedwith the sleeve 106 a. As shown, the sheath 107 a is in a firstposition, which exposes the distal end 117 a of the needle 102 a, andthe piston 109 a is covering the proximal end 119 a of the needle 102 a.The needle support 181 a of the housing 104 a is received in the channel173 a of the piston 109 a and is abutted with the stop 174 a. Theextension locking member 118 a of the sheath 107 a is received withinthe inner chamber 184 a of the housing 104 a and abuts against theshoulder 146 a of the housing 104 a. Thus, in the state of theembodiment shown, the biasing member 108 a is compressed between thesheath 107 a and the piston 109 a, which are held in a stable firstposition relative to each other.

When a blood collection vial is distally pressed against the proximalflange 171 a of the piston 109 a, the piston 109 a is moved distally.Similar to the discussion above concerning the tracks 113-115 of theblood collection safety device 100, the guide member 111 a can be movedfrom the initial track 113 a, to the transfer track 114 a, and then tothe engagement track 115 a. The movement of the guide member 111 a alongthe angled transfer track 114 a can rotate the sheath 107 a (relative tothe piston 109 a and the housings 104 a, 106 a).

The rotation of the sheath 107 a can rotate the extension locking member118 a. In certain embodiments, rotation of the sheath 107 a rotates theextension locking member 118 a into longitudinal alignment with thenotch 149 a in the shoulder 146 a of the housing 104 a. In such cases,when the extension locking member 118 a is aligned with the notch 149 a,the extension locking member 118 a can be allowed to pass distallythrough the notch 149 a. The sheath 107 a can thus be moved distally bythe bias of the biasing member 108 a.

With regard to FIGS. 8A-8D, the blood collection safety device 100 a isillustrated in an extended and locked position. As shown, the sheath 107a has moved distally. In some cases, the flange 185 a abuts with theshoulder 146 a, thereby inhibiting further distal movement. Normally,after the distal end 117 a of the needle 102 a is removed from thepatient, the sheath 107 a covers the distal end 117 a of the needle 102a.

In some embodiments, the sheath 107 a moves distally such that thefinger 186 a is distal of the piston 109 a, thereby permitting the biasof the finger 186 a to deflect a portion of the finger 186 a, e.g.,radially outwardly. In the deflected position, the finger 186 a canpresent an interference with the distal shoulder 190 a of the piston 109a. Thus, the outwardly deflected finger 186 a can inhibit the sheath 107a from being deflected proximally with respect to the piston 109 a. Forexample, the finger 186 a can inhibit the sheath 107 a from beingre-received into the piston 109 a.

In some embodiments, the sheath 107 a moves distally such the tooth 189a abuts the distal shoulder 190 a of the piston 109 a. In some suchembodiments, the tooth 189 a can inhibit the sheath 107 a from beingdeflected distally with respect to the piston 109 a.

In embodiments having both the finger 186 a and the tooth 189 a, whenthe finger 186 a and the tooth 189 a are engaged with the shoulder 190a, the plunger 105 a assembly is locked, e.g., the sheath 107 a and thepiston 109 a are substantially constrained relative to each other. Insuch configurations, the flange 185 a abutting the shoulder 146 ainhibits distal movement of the plunger assembly 105 a and the needlesupport 181 a abutting the stop 174 a inhibits proximal movement of theplunger assembly 105 a. Such embodiments of the blood collection safetydevice are therefore locked at both ends and can provide, for example, afurther impediment or reduction in the opportunity to accidentallycontact either end 117 a, 119 a of the needle 102 a. For example, boththe sheath 107 a covering the distal end 117 a and the piston 109 acovering the proximal end 119 a are substantially locked, e.g., cannotbe moved along the longitudinal axis to expose the ends 117 a, 109 a.

FIGS. 9A and 9B illustrate a further embodiment of a blood collectionsafety device 100 b. Several features and components of the bloodcollection safety device 100 b are identical or similar in form andfunction to those described above with respect to the blood collectionsafety devices 100, 100 a, and have been provided with like numerals,with the replacement of “a” with “b”. To the extent that parts of theblood collection safety device 100 b differ from those of the bloodcollection safety devices described above, some of those differences aredescribed and explained herein. Any features and/or components of thedisclosed embodiments can be combined or used interchangeably.

As shown, the blood collection safety device 100 b can include an outerhousing 104 b that is unitary, rather than two discrete portions (e.g.,a distal housing and a proximal housing). Such a configuration can, forexample, assist in manufacturability and/or assembly of the bloodcollection safety device 100 b. In some embodiments, the housing 104 bis monolithically formed, such as by molding.

FIGS. 10-14 illustrate a further embodiment of a blood collection safetydevice 100 c. Several features and components of the blood collectionsafety device 100 c are identical or similar in form and function tothose described above with respect to the blood collection safetydevices 100-100 b, and have been provided with like numerals, with theaddition of “c” (e.g., 100 c rather than 100 or 100 a). To the extentthat parts of the blood collection safety device 100 c differ from thoseof the blood collection safety devices described herein, some of thosedifferences are described and explained below. Any features and/orcomponents of the disclosed embodiments can be combined or usedinterchangeably.

The blood collection safety device 100 c can include a removable cap 101c, a needle 102 c with a distal end 117 c, an outer housing 104 c, and aplunger assembly 105 c. In some embodiments, the outer housing 104 cincludes a gap 192 c. For example, the gap 192 c can be disposed in aradially reducing shoulder 193 c of the outer housing 104 c. In somecases, the gap 192 c is a through-hole between the outside and theinside of the outer housing 104 c.

In some embodiments, the blood collection safety device 100 c includes atamper-resistant label 191 c. For example, the label 191 c can beadhered to the housing 104 c and the cap 101 c. In some configurations,the label 191 c is configured to rip, break, crease, or otherwiseprovide an indication upon the cap 101 c being separated from thehousing 104 c. In some cases, the label 191 c provides an area for theuser to mark, e.g., the user can use ink to note the patient name, dateof use of the device, etc. In certain configurations, the label 191 c isremovable from the housing 104 c (FIG. 11).

As shown in FIG. 12, in some embodiments, the blood collection safetydevice 100 c includes a hub 194 c. The hub 194 c can connect, e.g., byadhesive, with the needle 102 c through a central passage. The hub 194 ccan include a needle support 181 c, an annular portion 195 c, and adistally extending arm 196 c. In some cases, the distally extending arm196 c is configured to engage the gap 192 c of the outer housing 104 c.For example, in certain cases the arm 196 c includes a wedge, tab,tooth, or otherwise, which can snap into the gap 192 c, thereby couplingthe hub 194 c with the outer housing 104 c. In certain arrangements,such coupling is generally permanent, e.g., the hub 194 c is not removedfrom outer housing 104 c during normal and intended use of the bloodcollection safety device 100 c.

In some embodiments, such a configuration can facilitate assembly of theblood collection safety device 100 c. For example, as shown in FIGS. 13and 14, in some cases the needle 102 c, plunger assembly 105 c, and thehub 194 c are assembled as a separate inner unit, then that inner unitis mated with the outer housing 104 c. In some such embodiments, thepiston 109 c is mated with the hub 194 c. For example, the needlesupport 181 c of the hub 194 c can be received in a channel 173 c of thepiston. A proximal portion of the biasing member 108 c can be seated ona distally extending portion 175 c of the piston 109 c. The biasingmember can be received into the central lumen of the sheath 107 c andcan be seated on the distally extending portion 163 c. The sheath 107 ccan be moved toward the piston 109 c (or the piston 109 c can be movedtoward the sheath 107 c), thereby compressing the biasing member 108 c.A guide member 111 c of the sheath 107 c can be received through adistal open notch 178 c (not shown) in the engagement track 115 c of thepiston 109 c.

In some embodiments, the sheath 107 c can be rotated with respect to thepiston 109 c (or the piston 109 c can be rotated with respect to thesheath 107 c) such that the guide member 111 c is received in anassembly track 177 c. In some embodiments, the guide member 111 c ridesup the incline of the assembly track 177 c until reaching a generallyflat face 179 c (not shown), at which point the guide member 111 c cansnap to the bottom of the initial track 113 c. In such a condition, thesheath 107 c and the piston 109 c are held generally stable against thebias of the biasing element 108 c. For example, distal movement of thesheath 107 c and proximal movement of the piston 109 c can be inhibitedby a proximal wall of the initial track 113 c of the piston 109 cabutting the guide member 111 c of the sheath 107 c.

In some embodiments, the inner unit (e.g., needle 102 c, plungerassembly 105 c, and hub 194 c) is received into the housing 104 c. Thedistally extending arm 196 c can be coupled with the gap 192 c. Theextension locking member 118 c can be received in the inner chamber 184c and can abut the shoulder 146 c. In some such configurations, theplunger assembly 105 c is thus retained by the housing 104 c. In someembodiments, the sleeve 106 c is mated with the housing 104 c.

FIGS. 15-27 illustrate yet a further embodiment of a blood collectionsafety device 200. Several features and components of the bloodcollection safety device 200 are identical or similar in form andfunction to those described above with respect to the blood collectionsafety devices 100-100 c. To the extent that parts of the bloodcollection safety device 200 differ from those of the blood collectionsafety devices described herein, some of those differences are describedand explained below. Any features and/or components of the disclosedembodiments can be combined or used interchangeably.

With reference to the assembled views of FIGS. 15-15C, as well as theexploded view of FIG. 16, an embodiment of the blood collection safetydevice 200 is illustrated. In certain configurations, the device 200 canbe configured to mate with a blood collection vial or other container oradaptor (not shown). As illustrated, some embodiments of the device 200include a needle 202, a sheath 204, and a housing 206 that are generallyaligned along a longitudinal axis L. Certain implementations furtherinclude an intermediate member 208 and a piston 210, which can also begenerally aligned along the axis L. Some embodiments include a biasingmember 212, such as a spring. In certain variants, the device 200includes a resilient boot 214. In some implementations, the device 200includes a sleeve 216.

The blood collection safety device 200 can comprise features andcomponents that automatically inhibit, prevent, or otherwise discourageusing the device 200 multiple times, or inadvertently inserting theneedle 202 into a second person, such as a healthcare worker or anotherpatient. For example, certain embodiments of the blood collection safetydevice 200 include a locking system that automatically or passivelyinhibits access to the distal end 203 of the needle 202 after a singleuse of the device 200. Such embodiments can, for example, reduce thelikelihood of transferring blood or tissue-born diseases from onepatient to another. The locking system and/or reuse-inhibition featuresof the device 200 could be used with many different types of medical andnon-medical products.

In certain embodiments, the device 200 includes a cap 218. The cap 218can be configured to couple with the sheath 204, housing 206, orintermediate member 208. Some variants of the cap 218 can receive atleast a portion of the needle 202, such as the distal end 203. Certainvariants of the cap 218 can reduce or prevent contamination of theneedle 202, for example, during shipping and storage of the device 200.Typically, the cap 218 is removed prior to a blood collection procedure,at which time the cap 218 can be discarded.

In some implementations, the needle 202 includes a distal end 203 and aproximal end 205, each of which can comprise a sharp end. The needle 202can have an intermediate aperture 207 (not shown) that extends radiallythrough a side of the needle 202. In certain variants, fluid passingthrough the needle 202 can exit the needle 202 via the intermediateaperture 207.

The sheath 204 can be configured to expose the distal end 203 of theneedle 202 in certain modes of the device 200. In other modes, thesheath 204 can be configured to cover (e.g., include a portion thatextends distally beyond) the distal end 203 of the needle 202. In someembodiments, as will be discussed in further detail below, the sheath204 can be configured to reciprocate, telescope, or otherwise be atleast partly received within the housing 206. In some embodiments, thesheath 204 is configured to rotate with respect to the housing 206.

The piston 210 can be configured to expose the proximal end 205 of theneedle 202 in certain modes of the device 200. In other modes, thepiston 210 can be configured to cover (e.g., include a portion thatextends proximally beyond) the proximal end 205 of the needle 202. Insome embodiments, as will be discussed in greater detail below, thepiston 210 can be configured to reciprocate, telescope, or otherwise beat least partly received within the intermediate member 208.

With regard to FIGS. 17-17D, an embodiment of the housing 206 isillustrated. In some implementations, the housing 206 includes anelongate hollow body 220, a distal end 221, and a proximal end 222. Thehousing 206 can also include a distal aperture 223. In certainembodiments, the distal aperture 223 includes one or more indicationchannels 224. As illustrated, some embodiments of the indicationchannels 224 extend radially outwardly. Certain embodiments include aradially inwardly extending shoulder 225. For example, the shoulder 225can have a generally conical or generally hemispherical shape. Someimplementations have a recess 220′ (FIG. 17C) on an inner wall of thebody 220.

In some embodiments, the body 220 includes an indication element, suchas an indication face 226. In certain variants, the indication face 226comprises a pointed, flattened, or recessed portion. In someembodiments, the indication face 226 comprises an indicia, such as anarrow or line (e.g., applied with paint or ink). In certainimplementations, the indication face 226 is generally aligned with thebevel of the distal end 203 of the needle 202, thereby providing avisual and/or tactile indication of the orientation of the needle bevel.In some embodiments, a user is able to readily discern the orientationof the bevel, which can be helpful in performing certain blood drawprocedures.

In some implementations, the housing 206 includes one or more long andnarrow generally radially extending positioning members, such as prongs227. In certain embodiments, the prongs 227 extend radially outwardlyfrom the body 220 and have a generally sloped shape. In some variants,the housing 206 has long and narrow generally longitudinally extendingmembers, such as tabs 228, that extend proximally from the body 220. Thetabs 228 can include one or more securing members, such as clasps 229.

As illustrated in FIGS. 17C and 17D, some embodiments of the housing 206include a frame 230 within the body 220. In certain implementations, theframe 230 includes a distal end 231, a proximal end 232, and alongitudinal conduit 233. In some embodiments, the proximal end 232includes first and second movement regulating members, such as a valley234 and a ramp 235. As will be discussed in more detail below, in someembodiments, the longitudinal conduit 233, valley 234, and ramp 235 areconfigured to interface with features of the sheath 204 to restrainand/or allow distal movement of the sheath 204. The longitudinal conduit233 can be generally aligned with the indication channel 224.

Certain implementations of the frame 230 have at least one resilientflexing member, such as a leg 236. Typically, the leg 236 is configuredto flex, e.g., radially outward. In certain implementations, the housing206 is configured to facilitate flexing the leg 236. For example, someembodiments have longitudinal gaps 237 with the leg 236 disposedtherebetween. In some variants, the distal aperture 231 includes arecessed portion configured to allow for movement of the leg 236 (seeFIG. 17C). In some embodiments, the leg 236 includes an interferencemember, such as a tooth 238, edge, ledge, or the otherwise. Somevariants of the tooth 238 have a curved or sloped face. As illustrated,in some embodiments, the tooth 238 is angled toward the distal end 221.

With reference to FIGS. 18-18B, an embodiment of the sheath 204 isillustrated. In some embodiments, the sheath 204 includes a hollowcasing 240, a distal end 241, and a proximal end 242. Typically, atleast some of the distal end 241 of the sheath 204 is sized and shapedto be able to pass through the distal aperture 223 of the housing 206.In some embodiments, the sheath 204 has a longitudinal length that isless than a longitudinal length of the housing 206.

As illustrated, certain implementations of the sheath 204 include adistal hole 248, which can be configured to allow a portion of theneedle 202 to pass therethrough. In some embodiments, the distal hole248 is sized so as to reduce the chance of, or generally avoid, theescape of blood through the distal hole 248 (e.g., in case blood leaksfrom the needle 202 after the blood collection procedure). For example,in some embodiments, a diameter of the distal hole 248 is about equal toan outside diameter of the needle 202. In some embodiments, the diameterof the distal hole 248 is substantially less than an outside diameter ofthe sheath 204. For example, in certain embodiments, the ratio of thediameter of the distal hole 248 to the outside diameter of the sheath204 is less than or equal to about ⅓, about ¼, about ⅛, about 1/16,values in between, or otherwise.

In some embodiments, the sheath 204 includes radially extending guidemembers, such as wings 243, that extend radially outward from the casing240. Some embodiments of the wings 243 extend in generally oppositedirections. In certain implementations, the wings 243 includecircumferentially extending guide members, such as winglets 244. Incertain embodiments, the winglets extend circumferentially, relative tothe casing 240. In some variants, the winglets 244 extend generallyperpendicular to the wings 243. In certain implementations, the sheath204 includes at least one base guiding member, such as a foot 245 (e.g.,at the proximal end 242). In some embodiments, the foot 245 extendsgenerally radially outward from an outer surface of the casing 240. Incertain variants, the foot 245 has one or more slanted surfaces. In someembodiments, the wings 243 extend radially outward further than the foot245.

In some embodiments, the sheath 204 includes a distal opening 246. Incertain variants, the sheath 204 includes a proximal opening 247. Asillustrated, in some embodiments, the distal and/or proximal openings246, 247 are radial openings in the casing 240. As will be discussed ingreater detail below, in certain embodiments, the distal opening 246 andthe proximal opening 247 can be configured to interface with features ofthe housing 206 to inhibit certain movements of the sheath 204.

Some implementations of the sheath 204 have a longitudinally taperedconfiguration. For example, the proximal end 242 of the sheath 204 canbe radially thicker than the distal end 241 of the sheath 204. In someembodiments, the distal end 241 is radially thicker than the proximalend 242. A tapered configuration can, for example, facilitatemanufacturability. For example, a tapered configuration can aid inremoving the sheath 204 from molds, dies, tooling, or otherwise.

With regard to FIGS. 19-19D, an embodiment of the intermediate member208 is illustrated. Some embodiments of the intermediate member 208include a body portion 250, distal end 251, and proximal end 252. Incertain variants, the proximal end 252 comprises a connection member,such as threads. In some embodiments, the body portion 250 includes anengagement structure, such as longitudinal slots 253.

In certain implementations, the intermediate member 208 includes amovement facilitating member, such as a hollow rail 254. In someimplementations, the rail 254 has a longitudinal length that is greaterthan the longitudinal length of the sheath 204. In some embodiments, therail 254 is coupled with the body portion 250 via one or more arms 255that extend radially outward from the rail 254 (see FIG. 19D). Incertain implementations, the arms 255 extend in generally oppositedirections. In some embodiments, the body portion 250 includes aradially inwardly extending movement limiting member, such as a shoulder259. In some variants, the shoulder 259 includes a movement enablingstructure, such as one or more spaces 259′.

In some embodiments, the body portion 250 and the rail 254 are a singleunitary component. For example, the body portion 250 and the rail 254can be molded as a monolithic item. Such a configuration can, forexample, facilitate assembly of the device 200. In some embodiments, thebody portion 250 and the rail 254 are separate components. Such aconfiguration can, for example, facilitate molding or otherwise formingeach of these components. For example, in some implementations, theslots 253 include key receiving portions and the arms 255 include keyedends, which can be configured to engage with the key receiving portions.In certain such embodiments, the key receiving portions have a generallytriangular or keystone shape, and the keyed ends have a correspondingshape.

In some implementations, the rail 254 has a longitudinally taperedconfiguration. For example, a proximal end of the rail 254 can beradially thicker than a distal end of the rail 254. In some embodiments,the distal end of the rail 254 is radially thicker than the proximal endof the rail 254. As noted above, a tapered configuration can, forexample, facilitate manufacturability. For instance, a taperedconfiguration can aid in removing the rail 254 from molds, dies,tooling, or otherwise.

In some embodiments, the rail 254 is configured to facilitate movementof the sheath 204 along, or adjacent to, at least a portion of the rail254, as will be discussed in more detail below. For example, the rail254 can be configured to facilitate sliding movement of the sheath 204along the rail 254. Such a configuration can, for example, reduce thelikelihood of misalignment (e.g., kinking, bending, or other movementaskew from the longitudinal axis L) of the sheath 204 during use of thedevice 200. In some embodiments, an inner surface of the sheath 204contacts or is positioned adjacent to a radially outer surface of therail 254. In certain embodiments, at least some of the rail 254 isreceived in the sheath 204. For example, in some implementations,regardless of the position of the sheath 204, at least about ⅛, about ¼,about ⅓, about ½, or values in between, of the longitudinal length ofthe sheath 204 receives a portion of the rail 254.

In certain embodiments, the distal end 251 of the intermediate member208 extends beyond the distal end 221 of the housing 206. For example,in some embodiments, the rail 254 extends beyond the distal end 221 ofthe housing 206. Such a configuration can, for example, further reducethe chance of, or generally avoid, misalignment of the sheath 204.

As illustrated in FIG. 19A, the proximal end 252 of the intermediatemember 208 can include abutment members 256. As shown, the abutmentmembers 256 can extend proximally and can be configured to engage thesleeve 216 (e.g., the partition 283), for example, to limit the distalmovement of the sleeve 216 relative to the intermediate member 208. Insome embodiments, the intermediate member 208 includes a plurality offirst engagement members, such as resilient struts 257, which caninclude a radially inwardly extending portion. In certain variants, theintermediate member 208 includes a plurality of second engagementmembers, such as resilient arms 258. As shown, the resilient arms 258can include a radially inwardly extending portion. As will be discussedin more detail below, the resilient struts 257 and the resilient arms258 can be configured to engage and/or disengage with features of thepiston 210.

With reference to FIG. 19C, in some embodiments, the intermediate member208 includes a flash assembly 260 configured to signal the presence ofblood, which can indicate that the needle 202 is properly placed in thepatient. In some implementations, the flash assembly 260 includes aconduit 261 in fluid communication with the intermediate aperture 207 ofthe needle 202. Some embodiments of the conduit 261 can be disposedwithin one or more of the arms 255 of the intermediate member 208. Insome embodiments, the conduit 261 is disposed generally perpendicular tothe needle 202. In certain implementations, the conduit 261 extendsradially outward from the rail 254.

In some embodiments, the flash assembly 260 includes a filter 262. Incertain implementations, the filter 262 is an air pass filter, which canbe configured to allow air and other gases to pass therethrough, butinhibit or prevent the passage of blood therethrough. For example, thefilter 262 can include a hydrophobic material, such aspolytetrafluoroethylene. In certain variants, the filter 262 is visiblefrom on the exterior of the device 200. For example, as shown, theintermediate member 208 can include a recess or window through which thefilter 262 can be observed. As will be discussed in further detailbelow, in some configurations, the filter 262 can be contacted by bloodvia the needle 202 and the conduit 261.

In some embodiments, the filter 262 is configured to change state aftercontacting liquid, such as blood. For example, in some cases, the filter262 is configured to change color. In some implementations, the filter262 changes color from white to blue. Of course, various other initialand changed color states of the filter 262 are contemplated (e.g., pinkto green, black to white, orange to grey, purple to yellow, combinationsthereof, or otherwise). In some embodiments, the initial color of thefilter 262 is darker than the changed color of the filter 262. In otherembodiments, the initial color of the filter 262 is lighter than thechanged color of the filter 262. In certain implementations, the filter262 is configured to change color in a period of less than or equal to:about 0.5 seconds, about 1 second, about 1.5 seconds, about 2 seconds,about 3 second, values in-between, or otherwise. In some embodiments,the filter 262 includes a porous material, such as Porex™ materialavailable from the Prorex Corporation.

In certain embodiments, employing a filter 262 configured to changecolor can provide a more readily visible indication than, for example,viewing blood directly in a flash chamber. For example, the filter 262can be configured to change to a color (e.g., bright blue or brightgreen) that can, in certain embodiments, be easier to discern than thedark magenta color that is typical for blood. Thus, in certainembodiments, the filter 262 can provide a more easily recognizedindicator, which in turn can, for example, reduce the likelihood oferroneous readings (e.g., interpreting the flash chamber to indicate thepresence of blood (and thus that the needle is properly placed), when infact blood is not present).

Furthermore, a color changing filter 262 can, for example, inhibit oravoid potential undesirable reactions. Some people experience anxiety,nausea, fainting, or other reactions at the sight of blood. Thus, inconventional devices that have a flash indicator in which blood isviewed directly (e.g., through transparent or translucent portions ofthe device and/or windows in the device), such undesirable reactionscould be provoked. However, in some embodiments, the filter 262 is atleast partly opaque, thereby reducing or eliminating the sight of bloodin the flash assembly 260. In certain such embodiments, the presence ofblood in the flash assembly 260 is indicated indirectly (e.g., by thecolor change of the filter 262), not directly, thereby inhibiting oravoiding certain undesirable reactions.

In some embodiments, the portion of the flash assembly 260 that isexternally visible is configured to be generally hidden from the patientduring some or all of the blood collection procedure. For example, thedevice 200 can include a generally opaque screening member that blocksor otherwise inhibits the patient from viewing the flash assembly 260.In some embodiments, the portion of the flash assembly 260 that isexternally visible is relatively small (e.g., has a diameter that isless than or equal to: about 2.0 mm, about 4.0 mm, about 6.0 mm, about8.0 mm, about 10.0 mm, about 12.0 mm, values in between, or otherwise)compared to the distance from the penetration sight to the patient'seyes, which can reduce the ability of the patient to see the flashassembly 260. In certain implementations, the portion of the flashassembly 260 that is externally visible has a diameter that is less thanthe diameter of the sheath 204.

In certain embodiments, the sleeve 216 is configured to reduce or avoidthe sight of blood. For example, because some vials are transparent,some or all of the sleeve 216 can be least partly opaque. Further,certain variants of the sleeve 216 have sufficient length to receivesome or all of the length of the vial. For example, certain embodimentsof the sleeve 216 have a length parallel to the axis L of at least about60 mm, about 65 mm, about 70 mm, about 75 mm, about 80 mm, about 85 mm,about 90 mm, about 100 mm, about 105 mm, values in between, orotherwise. Some variants of the sleeve 216 have sufficient length toreceive at least about 75% of the axial length of the vial. In certainembodiments, the sleeve 216 has a window (not shown) configured topermit person using the device 200 to view the amount of blood in thevial (e.g., to discern when to remove the vial from the device 200). Insome such embodiments, the window is disposed so as to inhibit theability of the patient to view blood in the vial through the window. Forexample, in certain variants, when the sleeve 216 is attached with theintermediate member 208, the window is generally not aligned with theindication face 226 of the housing 206. Such a configuration can reducethe chance of the patient seeing though the window in those embodimentsin which the indication face 226 is faced toward the patient during theblood collection procedure.

Some embodiments of the device 200 include other flash detectionstructures and methods. For example, some embodiments are configured toallow air or other gases within the needle 202 to escape into theambient environment by passing between the needle 202 and the boot 214.Such evacuation of air in the needle 202 can, for example, facilitateblood from a vessel flowing into the needle 202 (e.g., by the pressurein the vessel). Certain embodiments of the device 200 are configured toallow the visual detection of such blood. For example, the needle 202can include distinct and spaced-apart needle portions in fluidcommunication. Further, at least some of the device 200 can betransparent or translucent, which can allow visual detection of bloodbetween the needle portions or in other portions of the device (e.g., aviewing window).

Some embodiments also include a porous vent (not shown). The vent can beconfigured to permit the passage of air therethrough, yet prevent orinhibit the passage of blood therethrough. For example, the vent cancomprise a hydrophobic material, such as polytetrafluoroethylene. Incertain variants, the vent is disposed at or near a distal end of theboot 214. Further details regarding some example embodiments of flashdetection structures and methods that can be used with the devicesdisclosed herein are provided in U.S. Pat. Nos. 7,160,267; 7,226,432;7,396,343; and 7,530,967; each filed May 3, 2004, each of which isincorporated herein by reference in its entirety.

With reference to FIGS. 20-20B, an embodiment of the piston 210 isillustrated. Certain embodiments of the piston 210 include a hollow tube270, a distal end 271, and a proximal end 272. In some variants, theproximal end 272 has a generally rounded shape and/or has a smallerdiameter than the hollow tube 270. Such a configuration can, forexample, assist in mating with the blood collection vial (e.g., canfacilitate a substantially air-tight seal between the proximal end 272and the vial). In some embodiments, the proximal end 272 is generallyflat. Certain implementations of the piston 210 are configured toreceive at least some of the proximal end 242 of the sheath 204. Forexample, an inside diameter of the hollow tube 270 can be greater thanthe outside diameter of the sheath 204.

In some embodiments, the piston 210 includes one or more guidingstructures, such as channels 273 that extend longitudinally andterminate in stops 273′. Some variants have channels 273 with anincreased width at the distal end 271, which can, e.g., facilitateassembly. In certain embodiments, the distal end 271 of the piston 210includes one or more engagement structures, such as protrusions 274and/or flanges 275. As illustrated, certain variants of the protrusions274 and/or flanges 275 extend radially outward from the hollow tube 270.Some embodiments include one or more windows 276. In certainembodiments, the windows 276 are recesses in the hollow tube 270. Inother implementations, the windows 276 fully extend through the width ofthe hollow tube 270.

In certain implementations, the piston 210 includes one or moreengagement structures, such as notches 277 (e.g., wedge-shapedrecesses), at or near the proximal end 272. In certain variants, thepiston 210 includes one or more notches 277′ positioned distal of thenotches 277. The notches 277, 277′ can be generally circumferentiallyaligned (e.g., such that the notches 277, 277′ are generally collinearon a line generally parallel with the axis L). The notches 277, 277′ canbe configured to engage one or more features of the housing 206 orintermediate member 208 to inhibit unintentional proximal movement ofthe piston 210.

In some embodiments, the piston 210 includes a plurality of tracks. Forexample, the piston 210 can include a ramp track 278 and a longitudinaltrack 279. In certain implementations, the longitudinal track 279extends generally parallel with the axis L. In some embodiments, theramp track 278 has a non-longitudinal orientation, such as an angle,helix, spiral, curve, or other shape relative to the axis L. As will bediscussed in greater detail below, in certain embodiments, the tracks278, 279 can be configured to engage the foot 245 of the sheath 204,which can encourage rotation of the sheath 204 relative to the piston210, which in turn can facilitate distal movement of the sheath 204.

With regard to FIGS. 21 and 21A, an embodiment of the sleeve 216 isillustrated. In some embodiments, the sleeve 216 includes a hollowmember 280, a distal ends 281, and a proximal end 282. In someembodiments, the sleeve 216 is configured to couple with theintermediate member 208. For example, the distal ends 281 can havethreads configured to engage threads on the intermediate member 208. Incertain implementations, the sleeve 216 has a partition 283 with anopening 284 configured to receive the proximal end 272 of the piston210. In certain embodiments, the sleeve 216 includes a tapered couplingmember, such as a wedge 285. For example, the wedge 285 can be coupledwith the wall 283 and be near or adjacent the opening 284.

In some variants, the sleeve 216 includes retaining members, such asfingers 286, which can project radially inwardly. In certainembodiments, the fingers 286 project inward to a greater extent near thedistal end 281 than near the proximal end 282. The fingers 286 can, forexample, provide a friction fit with a blood collection tube, therebyinhibiting or preventing the tube from being pushed proximally by thebias of the biasing member 212.

With reference to FIGS. 22-22B, the device 200 in an initial state isillustrated. In certain embodiments, in the initial state, the sleeve216 is separate from the rest of the device 200. For example, in someembodiments, in the initial state, the sleeve 216 is not secured to theintermediate member 208. Such a configuration can, for example, providean arrangement in which the device 200 can be stored or shipped. In someembodiments, the device 200 is stored or shipped in a configuration thatincludes the cap 218, as shown in FIG. 15A.

In some embodiments, the prongs 227 of the housing 206 are received inthe slot 253 of the intermediate member 208. In certain implementations,the radially outer face of the prongs 227 is generally flush with theradially outer face of the intermediate member 208, thereby providing agenerally seamless aesthetic. Moreover, the tabs 228 of the housing 206can be configured to engage (e.g., by a snap connection with the clasps229) the shoulder 259 of the intermediate member 208, therebysubstantially permanently coupling the housing 206 and the intermediatemember 208. Thus, in certain embodiments, the housing 206 andintermediate member 208 are substantially stationary relative to eachother. Such a configuration can, for example, provide a stable locationon the device 200 for a person to use as a handhold (e.g., whentransporting the device 200, during the blood collection procedure,and/or in the course of disposal). In some embodiments, the recess 220′on the inner wall of the body 220 of the housing 206 can receive aportion of the protrusion 274 of the piston 210.

In certain embodiments, in the initial state, the sheath 204 isgenerally inhibited from moving, thereby inhibiting or preventingunintentional activation of certain features configured to promotesingle-use of the device 200. For example, in some embodiments, in theinitial state, the wings 243 of the sheath 204 can abut the valley 234of the frame 230 of the housing 208, thereby inhibiting distal movementof the sheath 204. In certain implementations, the engagement of thewings 243 and the valley 234 counteracts the biasing member 212, whichbiases the sheath 204 distally.

In some embodiments, in the initial state, the tooth 238 of the housing206 is received in the distal opening 246 of the sheath 204 (see FIG.22B). In some embodiments, the tooth 238 is configured to resistproximal movement of the sheath 204. For example, the tooth 238 can beangled proximally. In certain variants, a distal end of the distalopening 246 has a complementary shape with regard to the tooth 238. Forexample, both the tooth 238 and the distal opening 246 can be angledproximally.

In certain implementations, the piston 210 is engaged with theintermediate member 208. For example, the protrusion 274 of the piston210 can be at least partly received in one of the spaces 259′ of theintermediate member 208. In some arrangements, one or more of theflanges 275 of the piston 210 abuts the shoulder 259 of the intermediatemember 208. Thus, the piston 210 can be retained in the intermediatemember 208 although the biasing member 212 biases the piston 210proximally.

In some variants, the channel 273 of the piston 210 receives the arms255 of the intermediate member 208. In some such variants, distalmovement of the piston 210 is limited by the longitudinal length of thechannels 273. For example, in some embodiments, the arms 255 abut withthe stops 273′ after having traveled the longitudinal extent of thechannel 273, thereby inhibiting further distal movement of the piston210.

In certain embodiments, in the initial state, a portion of the piston210 extends proximally of the proximal end 205 of the needle 202.Typically, in the initial state, the piston 210 is inhibited orprevented from moving distally. Such a configuration can, for example,reduce the likelihood of the distal end 205 of the needle 202 becomingcontaminated or pricking a person. In other states, as will be discussedbelow, the piston 210 is configured to move distally (e.g., by a distalforce applied via the blood collection vial) and/or proximally (e.g., bythe bias of the biasing member 212).

As illustrated in FIG. 22A, in some embodiments, in the initial state,the struts 257 of the intermediate member 208 engage with the windows276 of the piston 210, thereby providing a radial interference andinhibiting the piston 210 from moving distally. Indeed, the struts 257and/or the windows 276 can be shaped or otherwise configured such thateven if a distal force is applied to the piston 210, the struts 257 andthe windows 276 remain engaged. In certain embodiments, in the initialstate, the resilient arms 258 of the intermediate member 208 engage thedistal notches 277′ of the piston 210, thereby providing a secondaryradial interference to resist movement.

Typically, the needle 202 is coupled with another component of thedevice 200. In some implementations, the needle 202 is mounted to therail 254. For example, the needle 202 can be joined or bonded with therail 254 with an adhesive, by welding (e.g., thermal or ultrasonic), orotherwise. As shown, the needle 202 can be received at least partlywithin the rail 254. In some variants, the rail 254 is at least partlyreceived within the sheath 204. In some embodiments, the sheath 204 isat least partly radially received in the housing 206. In certainimplementations, the housing 206 is at least partly received within theintermediate member 208. In some embodiments, the distal end 203 of theneedle 202 projects distally from the sheath 204 and the proximal end205 of the needle 202 projects distally from the intermediate member208.

In certain implementations, the proximal end of the rail 254 isconfigured to couple with the resilient boot 214. The proximal end ofthe rail 254 can have retaining features (e.g., ribs or radiallyoutwardly extending shoulders) upon which the boot 214 can be retained,such as by friction fit. As shown, the boot 214 can receive the proximalend 205 of the needle 202. The boot 214 can be configured to be piercedby the proximal end 205 of the needle 202. Further, some variants of theboot 214 are configured to substantially reseal upon removal of theproximal end 205 of the needle 202 from the boot 214.

As noted above, some embodiments of the device 200 include the biasingmember 212. In certain implementations, the biasing member 212 engagesand extends between the sheath 204 and the piston 210. In someembodiments, the biasing member 212 is positioned longitudinally betweenthe sheath 204 and the piston 210. In certain embodiments, the biasingmember 212 encourages the sheath 204 distally and/or the piston 210proximally. In certain implementations, the biasing member 212encourages the sheath 204 and the piston 210 apart. For example, thebiasing member 212 can encourage the sheath 204 and the piston 210 ingenerally opposite directions. In some embodiments, the biasing member212 engages the wings 243. In some embodiments, the biasing member 212engages one or more of the flanges 275 of the piston 210.

As illustrated, some embodiments include a single biasing member 212.Other embodiments include a plurality of biasing members. For example,some embodiments include a first biasing member configured to bias thesheath 204 and a second biasing member configured to bias the piston210. Such a configuration can, for example, reduce or avoid a change inthe bias on the sheath 204 when the piston 210 moves, or vice versa. Incertain variants, the first and second biasing members are at leastpartly radially nested.

Various biasing members 212 can be used, such as a helical spring,conical spring, wave-spring, belleville washers, or otherwise. In someembodiments, the biasing member 212 is a conical coil spring having afree length of about 100 mm and a spring rate of at least about 0.12N/mm through the linear portion of the spring's deflection. Otherconstructions can include softer or stiffer springs depending on theapplication, and can be constructed of substantially any suitablematerial. Progressive springs and/or multiple springs of varying lengthscan also be used, for example, to provide a variable effective springrate.

With reference to FIGS. 23-23D, the device 200 is illustrated with thesleeve 216 attached. As previously noted, in certain embodiments, in theinitial state, the sleeve 216 is separated from the rest of the device200. However, the sleeve 216 is normally attached prior to a bloodcollection procedure being performed. As illustrated, in certainimplementations, the sleeve 216 is attached by securing it to theintermediate member 208, such as with a threaded connection. In someembodiments, attachment of the sleeve 216 releases the piston 210,thereby placing the device 200 in a ready-to-operate state. Typically,the device 200 is placed into the ready-to-operate state at about thetime and/or location in which the device is to be used (e.g., at thebedside, phlebotomy chair, or otherwise).

In some embodiments, the sleeve 216 is configured to couple with theintermediate member 208 (e.g., via a threaded connection). In somevariants, such coupling can engage the wedge 285 of the sleeve 216 withthe struts 257 of the intermediate member 208. For example, the wedge285 can deflect the struts 257 radially outward. In some embodiments,the struts 257 are deflected such that they no longer engage the windows276 of the piston 210, thereby removing the radial interference betweenthe struts 257 and the windows 276. In certain implementations, theopening 284 in the sleeve 216 can receive a portion of the piston 210.

Generally, during a blood collection procedure, after removing the cap218 (if used) and taking surface prepatory steps (if appropriate, e.g.,applying a disinfectant to the surface), the distal end 203 of theneedle 202 can be placed against the patient's skin at the penetrationsite. The device 200 can then be moved distally, thereby moving thedistal end 203 of the needle 202 into the patient (e.g., through thepatient's skin and into a vein).

In certain embodiments, the device 200 is configured to facilitate ashallow insertion angle (e.g., less than or equal to about 30° relativeto the surface being penetrated) of the needle 202. A shallow angle ofinsertion can facilitate proper placement of the needle 202 and/orreduce discomfort associated with placement of the needle 202. In someembodiments, the sheath 204 includes a relatively small diameter, whichcan reduce radial interference between the sheath 204 and the surfacebeing penetrated, and thus facilitate the shallow insertion angle. Forexample, the sheath 204 can have an outside diameter of at least about3.0 mm and/or less than or equal to about 12.5 mm. In certainimplementations, the outside diameter of the sheath 204 is about 2.0 mm,about 3.0 mm, about 4.0 mm, about 5.0 mm, about 6.0 mm, about 7.0 mm,about 8.0 mm, about 9.0 mm, about 10.0 mm, values in between, orotherwise. As illustrated, the outside diameter of the sheath 204 can beless than an outside diameter of the housing 206.

In some embodiments, blood in the vein can be encouraged (e.g., bypressure in the vein) proximally through the needle 202. In certainembodiments, the blood can pass through the intermediate aperture 207 ofthe needle 202 and into the conduit 261 of the flash assembly 260. Asnoted above, the filter 262 can be an air-pass filter, therebypermitting air or other gases in the needle 202 and/or conduit 261 toescape. Thus, some embodiments of the device 200 are configured toinhibit air or other gases in the needle 202 and/or conduit 261 frompresenting an embolus that inhibits blood from contacting the filter262. As also noted above, the filter 262 can be visible on the exteriorof the device 200 and can be configured to exhibit a change (e.g., acolor change) after being contacted with blood. Accordingly, certainembodiments can provide the user of the device 200 a visual indicationof the blood having passed through the needle 202 and conduit 261, whichcan indicate, for example, that the needle 202 is properly placed in thepatient. Further, in certain embodiments, such an indication is madewithout visually exposing the blood itself.

When proper placement of the needle 202 in the patient has beendetermined, the blood collection portion of the procedure generallybegins. As illustrated in FIGS. 24-24B, during the blood collectionportion of the procedure, a distal end of the blood collection vial canbe abutted with the proximal end 272 of the piston 210. In someinstances, the user applies distal force to the blood collection vial,which in turn applies distal force to the piston 210 against the bias ofthe biasing member 212. The distal force on the piston 210, ifsufficiently large, can overcome the bias of the biasing member 212.Further, sufficient distal force on the piston 210 can result in theresilient arms 258 of the intermediate member 208 being disengaged(e.g., being deflected radially outward) from the distal notch 277′ ofthe piston 210. Accordingly, the piston 210 can be moved distallyrelative to the needle 202.

In some embodiments, distal movement of the piston 210 results in theboot 214 being pressed against the blood collection vial. Continueddistal force can result in the proximal end 205 of the needle 202piercing the boot 214 and passing into the blood collection vial. Thus,blood can flow from the patient's vein into the blood collection vialvia the needle 202. In some embodiments, the flow of blood is encouragedby the blood collection vial being evacuated (e.g., under a vacuum).

In certain embodiments, as the blood collection vial moves the piston210 distally, the piston 210 moves relative to the sheath 204. In someembodiments, the ramp track 278 of the piston 210 engages the foot 245of the sheath 204. For example, the foot 245 can slide along the ramptrack 278, which can be non-axially oriented (e.g., angled, helixed,spiraled, curved, or otherwise shaped with regard to the axis L). As thefoot 245 slides along the ramp track 278, a torque can be created. Insome implementations, because the channel 273 of the piston 210 isengaged with the arms 255 of the intermediate member 208, the piston 210is inhibited from being rotated relative to the intermediate member 208by the torque.

In some embodiments, the sheath 204 can be rotated relative to thehousing 206, intermediate member 208, and/or piston 210 by the torque.For example, in the illustrated embodiment, distal movement of thepiston 210 can encourage the foot 245 to ride along the helical ramptrack 278, thereby rotating the sheath 204 relative to the intermediatemember 208. In certain variants, the sheath 204 is configured to rotateabout the longitudinal axis at least about 10° and/or less than or equalto about 120°. In some embodiments, the sheath 204 is configured torotate at least about 30° and/or less than or equal to about 60°. Insome implementations, the sheath 204 is configured to rotate at leastabout 15°, about 20°, about 25°, about 30°, about 35°, about 40°, about45°, about 50°, about 55°, about 60°, about 65°, about 70°, about 75°,about 80°, about 85°, about 90°, values in between, or otherwise. Incertain variants, with sufficient distal movement of the piston 210, thefoot 245 moves into the longitudinal track 279.

In some embodiments, rotation of the sheath 204 results in the distalopenings 246 of the sheath 204 being rotated out of engagement with thetooth 238 of the housing 206. For example, the tooth 238 can bedeflected radially outward by the hollow casing 240 of the sheath 204.

With regard to FIGS. 25-25B, in certain configurations, rotation of thesheath 204 results in the sheath 204 being released to move distally.For example, rotation of the sheath 204 can result in the wings 243 nolonger being inhibited in the distal direction by the valley 234 of theframe 230 of the housing 206. In some implementations, the wings 243 arerotated into alignment with the longitudinal conduit 233. The sheath 204can thus be moved distally, such as by the bias of the biasing member212.

In some implementations, after being released, the distal end 241 of thesheath 204 moves distally into abutment with the surface beingpenetrated by the needle 202 (e.g., the patient's skin). In certainembodiments, after the sheath 204 has been released, the sheath 204covers at least a portion of the needle 202 distal of the distal end 221of the housing 206 and remains biased distally by the bias of thebiasing member 212. In some variants, as the sheath 204 moves distally,the wings 243 pass through at least some the longitudinal conduit 233.

In certain implementations, the wings 243 slide along the ramp 235 priorto entering the longitudinal conduit 233, thereby providing a slightresistance. A resistance can, for example, provide feedback to the userof the device 200 that the sheath 204 is about to be released. Feedbackcan, for example, allow the user and/or patient to expect and/or preparefor movement of the sheath 204.

In some embodiments, the foot 245 of the sheath 204 is stationary withregard to the intermediate member 208, yet traverses through a portionof the longitudinal track 279 of the piston 210 due to the distalmovement of the piston 210. In some configurations, such as after thesheath 204 has been released to move distally, the foot 245 of thesheath 204 traverses through a portion of the longitudinal track 279(e.g., proximally) and is not stationary with regard to the intermediatemember 208.

In some variants, distal movement of the vial is limited by the abutmentmembers 256. For example, the abutment members 256 can present a rigidstop to the sleeve 216. Such a configuration can, for example, inhibitor prevent the sleeve 216 from being threaded too far distally relativeto other components, which could result in damage to the sleeve 216and/or other components of the device 200. For example, the abutmentmembers 256 can inhibit or prevent the partition 283 from contacting thedistal end of the rail 254, which could dislodge the boot 214.

As noted above, the vial or other container or adaptor can move thepiston 210 distally as the vial is being engaged with the device 200. Insome embodiments, when the distal end of the vial is nearly abuttedagainst the partition 283 of the sleeve 216, the resilient arms 258 ofthe intermediate member 208 engage with the proximal notch 277 of thepiston 210, which can counteract the force of the biasing member 212 andthus reduce or eliminate the amount of distal force that the user needsto apply to the vial to maintain it in position in the device 200. Sucha configuration can, for example, reduce the likelihood of the piston210 and/or the vial being inadvertently moved proximally by the biasingmember 212, which could result in a spill or aspiration of blood.

In various embodiments, if further samples of blood are desired, thevial can be disengaged from the device 200 by moving the vial 200proximally, thereby extracting the proximal end 205 of the needle 202from the vial. In certain implementations, as the vial is movedproximally, the biasing member 212 will encourage the piston 210proximally. In some embodiments, removal of the vial allows the piston210 and/or the boot 214 to return to its original position (e.g., havinga portion disposed proximal of the proximal end 205 of the needle 202).In certain implementations, the resilient arms 258 of the intermediatemember 208 re-engage with the distal notch 277′ of the piston 210, whichcan provide a slight resistance against incidental contact with thepiston 210. After disengagement of the vial, another vial or vials canbe engaged with the device 200.

After the desired number of samples has been collected, the usernormally moves the device 200 proximally, thereby extracting the distalend 203 of the needle 202 from the patient. In some embodiments, as thedistal end 203 of the needle 202 is extracted proximally, the sheath 204is automatically moved distally (e.g., relative to the distal end 203 ofthe needle 202) by the bias of the biasing member 212.

As illustrated in FIGS. 26-26D, after the needle 202 has been fullyremoved from the patient, the sheath 204 can move toward its fullydistal position. Generally, in the fully distal position, a portion ofthe sheath 204 is positioned distal of the distal end 203 of the needle202. Such a configuration can, for example, promote safety by shieldingpersons from the sharp distal end 203. Further, because the sheath 204is automatically moved to cover the distal end 203 of the needle 202,such a passive safety feature does not require the user to activate,trigger, or otherwise engage such a feature and diminishes the risk ofinadvertent harm to the patient and/or healthcare worker caused byfailure to deploy an active safety feature.

In some embodiments, distal movement of the sheath 204 is limited. Forexample, the winglets 244 of the sheath 204 can abut with an innersurface of the shoulder 225 of the housing 206, thereby inhibiting orpreventing further proximal movement of the sheath 204. As illustrated,in some embodiments, the winglets 244 are positioned radially outward ofthe frame 230 of the housing 206.

In some configurations, proximal movement of the sheath 204 is limited.In certain embodiments, when the sheath 204 nears its fully distalposition, the tooth 238 of the frame 230 of the housing 208 engages theproximal opening 247 of the sheath 204. Typically, the tooth 238 and theproximal window 247 are configured to resist proximal movement of thesheath 204. For example, the tooth 238 can be angled proximally. Incertain variants, a distal end of the proximal opening 247 has acomplementary shape with regard to the tooth 238. For example, both thetooth 238 and the proximal opening 247 can be angled proximally.

Generally, when the sheath 204 has moved to its generally fully proximalposition, it is retrained from moving distally (e.g., by the abutment ofthe winglets 244 with the shoulder 225) and proximally (e.g., byengagement of the tooth 238 and the proximal window 247). In someconfigurations, the sheath 204 is described as being in a locked-outstate. In the locked-out state, the distal end 203 of the needle 202generally cannot be re-exposed, thereby preventing inadvertent stickingwith the distal end 203. Further, as reuse of the device 200 isgenerally not possible when the sheath 204 is in the locked-out state,the device 200 can avoid the risk of transmitting blood-born pathogensthat could occur when needles are reused.

Certain variants include an indication that the sheath 204 issubstantially at its fully distal position. For example, in someembodiments, when the winglets 244 abut with the shoulder 225, a portionof the wings 243 extend at least partly through the indication channel224 of the housing 206. In some such embodiments, the wings 243 can bevisually observed external of the device 200, thereby providing a signalthat the sheath 204 is generally in its fully distal position.

As noted above, the sleeve 216 can be configured to attach to othercomponents of the device 200. For example, the sleeve 216 can attach tothe intermediate member 208 with a threaded connection. Certainembodiments of the sleeve 216 are also configured to be removable. Forexample, some variants of the sleeve 216 can be removed from theintermediate member 208 by unscrewing the threaded connection. In someembodiments, removal of the sleeve 216 disengages the wedge 285 from thestruts 257 of the intermediate member 208. In some implementations, suchdisengagement results in the struts 257 of the intermediate member 208re-engaging with the windows 266 of the piston 210, thereby inhibitingfurther distal movement of the piston 210. Such a configuration can, forexample, reduce the likelihood of a needle stick with the proximal end205 of the needle 202.

Therefore, certain embodiments of the device 200 provide apassively-locking single-use blood collection instrument. In someembodiments, the proximal end 205 of the needle 202 can be renderedgenerally safe when the sleeve 216 is removed from the device 200. Insome embodiments, the distal end 203 of the needle 202 can be renderedgenerally safe after the piston 210 has been moved distally (e.g., byinsertion of the vial) and the sheath 204 has been allowed to travel toits fully distal position. Indeed, certain embodiments of the device 200can render generally safe both the distal and proximal ends 203, 205,thereby providing protection at both ends of the needle 202. Someembodiments of the device 200 provide protection even after the sleeve216 has been removed. Furthermore, the locking features of the device200 can prevent reuse.

With reference to FIG. 27, after the blood collection procedure has beencompleted, the device 200 is normally disposed of Disposal of devicesincluding needles and other types of medical waste are generally subjectto laws, codes, and/or regulations requiring special “sharps” disposalmethods and procedures. For example, many states require that itemsincluding needles be disposed of in dedicated rigid leak-proofcontainers and be disposed of in particular locations and/or byhazardous waste organizations. In many instances, the cost to dispose of“sharps” waste is weight-based and can be quite expensive due to thespecial care that such waste requires. Therefore, it can be desirable toreduce the weight (and thus the cost of disposal) of items that will besubject to “sharps” disposal requirements. In some embodiments, aportion of the device 200 comprising a substantial proportion of theweight of the device 200 can be disposed of in a non-“sharps” disposalreceptacle. For example, as certain embodiments of the sleeve 216 do notinclude a needle, the sleeve 216 typically can be disposed of asstandard waste or non-“sharps” waste. Likewise, in certain embodiments,the cap 218 can be configured to be removed from the rest of the device200 and be disposed as standard waste or non-“sharps” waste. Thus,removal of the sleeve 216 and/or cap 218 can reduce the weight of thedevice 200 that is disposed of as “sharps” waste, which in turn canreduce the cost to dispose of the device 200. In some embodiments, amethod of manufacturing or providing a blood connection device 200 caninclude instructing healthcare providers and/or patients to dispose of aportion of the device 200 in a “sharps” receptacle and to dispose ofanother portion of the device 200 in an ordinary and/or conventionalmedical refuse receptacle.

As noted above, some embodiments device 200 may be configured fordisposal in a non-“sharps” disposal receptacle. For example, some or allof the device 200 can be disposable as hazardous waste or othernon-“sharps” waste. Certain variants may be disposable as non-“sharps”waste at least partly due to the needle 202 being substantially,substantially entirely, or entirely contained in the device 200 afterthe device 200 has been used (e.g., in a blood collection procedure),thereby greatly reducing or eliminating the potential of the needle 202to pierce or rupture the disposal container (e.g., a plastic bag orcardboard box) and/or to produce skin laceration or puncture injuries.For example, as discussed above, after the device 200 has been used, aportion of the sheath 204 can extend beyond and cover the distal end 203of the needle 202 and a portion of the piston 210 can extend beyond andcover the proximal end 203 of the needle 202. Further, the sheath 204and the piston 210 can be configured to lock, thereby preventing theneedle 202 from projecting from the sheath 204 and piston 210. Somevariants of the device 200 may be disposable as non-“sharps” wastebecause, for example, the device 200 can automatically and passivelysecure the sheath 204 and piston 210 after the device 200 has been used.

In certain configurations, portions of the device 200 can form aprotective enclosure around the needle 202, thereby reducing oreliminating the need for disposing the device 200 in a separate “sharps”container. For example, the sheath 204, housing 206, intermediate member208, and piston 210 can form a protective enclosure around the needle202 after the device 200 has been used. In certain embodiments, theprotective enclosure may render the device 200 suitable for disposal asnon-“sharps” waste, such as hazardous waste. In some variants, thesheath 204 and/or piston 210 include sealing elements (e.g., a resilientflap, septum, or otherwise) that are configured to generally seal thedistal hole 248 of the sheath 204 and/or the hollow proximal end 272 ofthe piston 210 at least after the device 200 has been used, therebyreducing the possibility of fluid (e.g., blood) from the needle 202leaking from the device 200.

In certain embodiments, after the device 200 has been used, the needle202 is substantially or completely obscured from view. In someembodiments, after the device 200 has been used, the only portions ofthe needle 202 that are visible from outside the device 200 are thedistal and proximal ends 203, 205. In certain implementations, after thedevice 200 has been used, the distal and proximal ends 203, 205 arevisible only through the distal hole 248 of the sheath 204 and thehollow proximal end 272 of the piston 210.

FIGS. 28-35 illustrate yet another embodiment of a blood collectionsafety device 300. The blood collection safety device 300 can usecomponents, portions, and/or features that are the same as or identicalto those described herein with respect to other blood collection safetydevices disclosed herein. Any features and/or components of thedisclosed embodiments can be combined or used interchangeably.

With reference to the assembled views of FIGS. 28 and 28A, as well asthe exploded view of FIG. 29, an embodiment of the blood collectionsafety device 300 is illustrated. In certain configurations, the device300 can be configured to mate with a blood collection vial or othercontainer or adaptor (not shown). As illustrated, some embodiments ofthe device 300 include a connector member 306, an intermediate member308, and a piston 310 that are generally aligned along a longitudinalaxis L. Certain implementations include a sleeve 316 that is generallyaligned along the axis L. In some embodiments, the sleeve 316 is similaror identical to the sleeve 216 described above. In certain variants, thesleeve 316 is removably secured to the intermediate member 308, such aswith threads, clips, friction fit, bayonet connection, or otherwise.Some embodiments include a biasing member 312, such as a spring. Forexample, in some variants, the biasing member 312 comprises a helicalspring, wave-spring, belleville washers, or otherwise.

As illustrated, the device 300 can include a needle 302 and a resilientboot 314. In some implementations, the needle 302 has a distal end 303and a proximal end 305. In certain embodiments, at least the proximalend 305 comprises a sharp tip (e.g., configured to pierce a cover of ablood collection vial). In certain modes of the device 300, the proximalend 305 of the needle 302 is covered by the piston 310 (e.g., a portionof the piston 310 extends proximally beyond the proximal end 305). Inother modes, the proximal end 305 of the needle 302 is exposed by thepiston 310. In some embodiments, as will be discussed in greater detailbelow, the piston 310 can be configured to reciprocate, telescope, move,or otherwise be at least partly received within the intermediate member308.

With regard to FIGS. 30 and 30A, an embodiment of the connector member306 is illustrated. In some implementations, the connector member 306includes an elongate hollow body 320, a distal end 321, and a proximalend 322. In some embodiments, a portion of the proximal end 322 includesa retaining feature, such as a flange, that is configured to connectwith the resilient boot 314 (e.g., by a friction fit). In some variants,the connection between the boot 314 and the proximal end 322 issubstantially liquid tight. As illustrated, the connector member 306 caninclude a distal aperture 323 in fluid communication with the hollowbody 320.

Some embodiments of the connector member 306 include a medical connectorinterface 324, which can be configured to engage with any suitablemedical connector. For example, the medical connector interface 324 canbe configured to engage with a needleless IV access device. Asillustrated, the medical connector interface can comprise a male luerwith a luer-lock shroud configured to be inserted into a correspondingfemale luer connector or another medical device, such as a catheter orshunt, connected to a patient. Many other structures and configurationscan be used. For example, the medical connector interface 324 cancomprise a female luer connector configured to be attached to a maleluer connector on another medical device. In some embodiments, themedical connector interface 324 is threaded, configured to accept a Luerconnector, or otherwise shaped to attach directly to a medical device orother instruments. In certain variants, the medical connector interface324 includes a passage or channel, such as a length of tubing. Asillustrated, certain embodiments include a radially outwardly extendingshoulder 325, which can be generally flat, generally curved, orotherwise shaped.

In some embodiments, the connector member 306 includes one or moresupport members, such as ribs 327. In some embodiments, a portion of theribs 327 extends generally longitudinally along a portion of theelongate body 320. In certain variants, a portion of the ribs 327extends generally outwardly along a portion of the shoulder 325. Certainembodiments of the ribs 327 are configured to support a portion of thebiasing member 312. For example, the ribs 327 can be configured toposition a distal end of the biasing member 312 and/or inhibit thebiasing member 312 from becoming misaligned with respect to the elongatebody 320. Some implementations of the struts are configured tofacilitate generally longitudinal sliding movement of the piston 310along a portion of the elongate body 320. For example, the ribs 327 canreduce friction between the piston 310 and the elongate body 320 and/orcan help to align the piston 310 with respect to the elongate body 320.

With regard to FIGS. 31 and 31A, an embodiment of the intermediatemember 308 is illustrated. Some embodiments of the intermediate member308 include a generally hollow body portion 350, distal end 351, andproximal end 352. In certain variants, the proximal end 352 comprises aconnection member, such as threads. In some embodiments, the bodyportion 350 includes an engagement structure, such as at least onelongitudinal slot 353. In certain embodiments, the slot 353 ispositioned on a radially inner surface of the body portion 350. Somevariants include a guide structure, such as a fence 354, on one or moresides of the slot 353.

The proximal end 352 of the intermediate member 308 can include aplurality of first engagement members, such as resilient struts 357,which can include a radially inwardly extending portion. In certainvariants, the intermediate member 308 includes a plurality of secondengagement members, such as resilient arms 358. As shown, the resilientarms 358 can include a radially inwardly extending portion. Similar tothe resilient struts 257 and the resilient arms 258 discussed above inconnection with device 200, the resilient struts 357 and the resilientarms 358 can be configured to engage and/or disengage with certainfeatures of the piston 310. In some embodiments, the resilient struts357 and/or the resilient arms 358 connect with, or extend proximallyfrom, a radially inwardly extending support member, such as a shoulder359, of the body portion 350. In some variants, the shoulder 359includes a movement enabling structure, such as one or more spaces 359′.

With reference to FIG. 32, an embodiment of the piston 310 isillustrated. The piston 310 can include a hollow tube 370, a distal end371, and a proximal end 372. In some embodiments, the proximal end 372has a generally rounded shape and/or has a smaller diameter than thehollow tube 370. Such a configuration can, for example, assist in matingwith the blood collection vial (e.g., can facilitate a substantiallyair-tight seal between the proximal end 372 and the vial). In someembodiments, the proximal end 372 is generally flat.

In certain embodiments, piston 310 includes one or more engagementstructures, such as protrusions 374 and/or flange 375. As illustrated,certain variants of the protrusions 374 and/or flanges 375 extendradially outward from the hollow tube 370. Some embodiments include oneor more windows 376. In certain embodiments, the windows 376 arerecesses in the hollow tube 370. In other implementations, the windows376 fully extend through the width of the hollow tube 370.

In certain implementations, the piston 310 includes one or moreengagement structures, such as notches 377 (e.g., wedge-shapedrecesses), at or near the proximal end 372. In certain variants, thepiston 310 includes one or more notches 377′ positioned distal of thenotches 377. The notches 377, 377′ can be generally circumferentiallyaligned (e.g., such that the notches 377, 377′ are generally collinearon a line generally parallel with the axis L). The notches 377, 377′ canbe configured to engage one or more features of the connector member 306or intermediate member 308 to inhibit unintentional proximal movement ofthe piston 310.

With reference to FIGS. 28 and 33, the device 300 in an initial state isillustrated. In certain embodiments, in the initial state, the sleeve316 is separate from the rest of the device 300. For example, in someembodiments, in the initial state, the sleeve 316 is not coupled withthe intermediate member 308. Such a configuration can, for example,provide an arrangement in which the device 300 can be stored or shipped.

In some embodiments, in the initial state, piston 310 is inhibited frommoving distally relative to the needle 302, thereby providing agenerally locked covering for the sharp proximal end 305 of the needle302 and decreasing the chance of an accidental needle stick. Forexample, in certain implementations, the piston 310 is inhibited frommoving distally relative to the needle 302 because the resilient struts357 of the intermediate member 308 engage with the windows 376 of thepiston 310, thereby providing a radial interference. In some variants,the struts 357 and/or the windows 376 can be shaped or otherwiseconfigured such that even if a distally-directed force is applied to thepiston 310, the struts 357 and the windows 376 remain engaged. Incertain embodiments, in the initial state, the resilient arms 358 of theintermediate member 308 engage the distal notches 377′ of the piston310, thereby providing a secondary radial interference to resistmovement.

In some embodiments, the sleeve 316 can be configured to couple with theintermediate member 308 (e.g., via a threaded connection). Similar tothe discussion above in connection with the engagement of the sleeve 216and the intermediate member 208 of the device 200, in some embodiments,engagement of the sleeve 316 and the intermediate member 308 candisengage the struts 357 of the intermediate portion 308 from thewindows 376 of the piston 310. For example, a wedge 385 of the sleeve316 can deflect the struts 357 radially outwardly, thereby removing theradial interference between the struts 357 and the windows 376.

With regard to FIG. 34, a cross-sectional perspective view of the device300 in a ready-to-operate state is illustrated. The ready-to-operatestate can occur, for example, after the sleeve 316 has been coupled withthe intermediate member 308. In certain embodiments, the device 300 isin the ready-to-operate state before a blood collection vial (not shown)has been engaged with the device 300. In some embodiments, the device300 is in the ready-to-operate state after a blood collection vial hasbeen disengaged from the device 300.

As illustrated in FIG. 34, the shoulder 325 of the connector member 306can be connected with the distal end 351 of the intermediate member 308,such as with adhesive, welding, or other techniques. In someimplementations, the ribs 327 of the connector member 306 extendradially outward along the shoulder 325 less than an inner diameter ofthe distal end 351 of the intermediate member 308, which can allow theshoulder 325 and the distal end 351 of the intermediate member 308engage in a generally flush manner.

In certain embodiments, the needle 302 is mounted in, or otherwiseconnected with, the connector member 306, such as with adhesive,welding, or other techniques. As illustrated, the needle 302 can bespaced apart from the medical connector interface 324 by a distancealong the axis L. A portion of the needle 302 can extend proximally fromthe connector member 306 and through a portion of the hollow tube 370 ofthe piston 310 and the boot 314 (not shown for clarity). As shown, inthe ready-to-operate state, a portion of the proximal end 372 of thepiston 310 can extend proximally of the proximal end 303 of the needle302, which can shield the sharp proximal end 305 and reduce thelikelihood of accidental needle sticks. In some arrangements, a portionof the piston 310 is received in, and projects proximally through, theaperture 384 of the sleeve 316.

As illustrated, a portion of the distal end 371 of the piston 310 can bereceived in the hollow body 350 of the intermediate member 308. Theflange 375 of the piston 310 can be received in the longitudinal slot353 and allowed to move therealong (e.g., with sliding reciprocatingmotion). In certain embodiments, the fence 354 is configured togenerally maintain the flange 375 in the slot 353 and/or to inhibitrotational movement of the piston 310 with respect to the intermediatemember 308. In certain implementations, a distance that the fence 354extends radially inwardly from the inner surface of the body portion 350is less than or equal to a distance that the flange 375 extends radiallyoutwardly from an outer surface of the hollow tube 370. For example, insome embodiments, the fence 354 extends radially inwardly from the innersurface of the body portion 350 less than or equal to about ½ of thedistance that the flange 375 extends radially outwardly from an outersurface of the hollow tube 370.

In some embodiments, the biasing member 312 (not shown for clarity) canbe positioned and/or compressed between the connector member 306 and thepiston 310. For example, a distal end of the biasing member 312 can beabutted against, or otherwise engaged with, the shoulder 325 of theconnector member 306, and a proximal end of the biasing member 312 canbe abutted against, or otherwise engaged with, the flange 375 of thepiston 310. In some implementations, the biasing member 312 biases thepiston 310 proximally. For example, in certain configurations, thebiasing member 312 encourages the piston 310 proximally such that theprotrusions 374 of the piston 310 abut or otherwise engage the shoulder359 of the intermediate member 308, thereby inhibiting further proximalmovement of the piston 310. In some embodiments, a distance between adistal-most edge of the flange 375 and a proximal-most edge of the ribs327 that extend generally outwardly along the shoulder 325 is less thanor equal to a distance between a proximal surface of a partition 383 ofthe sleeve 316 and the proximal end 372 of the piston 310.

During a blood collection procedure, the device 300 can be engaged witha medical connector (not shown). For example, the medical connectorinterface 324 can be rotated into threaded engagement with a needlelessIV access device or any other type of needleless port or access device.In some configurations, when the medical connector interface 324 isengaged with the medical connector, the needle 302 is in fluidcommunication with the medical connector and associated systems (e.g.,the venous system of the patient in which the IV is disposed), therebyallowing blood or other fluids to flow into the needle 302 via thedistal aperture 323 and hollow body 320. In some implementations, thedevice 300 is placed into the ready-to-operate state (e.g., as shown inFIG. 33) before being engaged with the medical connector. For example,the sleeve 316 can be engaged with the intermediate member 308 prior tothe medical connector interface 324 being engaged with the medicalconnector.

In certain embodiments, when a blood collection vial is not engaged withthe device 300, blood or other fluids in the needle 302 are inhibited orprevented from escaping from the device 300 by the boot 314. Forinstance, the boot 314 can be configured to inhibit or prevent blood orother fluids from escaping from the device 300 after the medicalconnector interface 324 has been engaged with the medical connector butbefore a blood collection vial has been engaged with the device 300. Insome embodiments, the boot 314 is connected with the proximal end 322 ofthe connector member 306 such that blood or other fluids in the needle302 are inhibited or prevented from passing therebetween and/or fromseparating the boot 314 from the proximal end 322.

In some implementations, after the device 300 has been engaged with themedical connector, the blood collection portion of the proceduregenerally begins. With reference to FIG. 35, during the blood collectionportion of the procedure, a distal end of the blood collection vial (notshown) can be abutted with the proximal end 372 of the piston 310. Insome instances, the user applies distal force to the blood collectionvial, which in turn applies distal force to the piston 310 against thebias of the biasing member 312. The distal force on the piston 310, ifsufficiently large, can overcome the bias of the biasing member 312.Further, sufficient distal force on the piston 310 can result in theresilient arms 358 of the intermediate member 308 being disengaged(e.g., being deflected radially outward) from the distal notch 377′ ofthe piston 310. Accordingly, the piston 310 can be moved distallyrelative to the needle 302.

In some embodiments, distal movement of the piston 310 results in theboot 314 being pressed against the blood collection vial. Continueddistal force can result in the proximal end 305 of the needle 302piercing the boot 314 and passing into the blood collection vial. Thus,blood can flow from the medical connector and associated systems (e.g.,the patient's vein) into the blood collection vial via the needle 302.In certain variants, the flow of blood is encouraged by the bloodcollection vial being evacuated (e.g., under a vacuum).

In some embodiments, when the distal end of the vial is moved distally adistance toward the partition 383 of the sleeve 316, the resilient arms358 of the intermediate member 308 engage with the proximal notch 377 ofthe piston 310. In certain embodiments, engagement of the resilient arms358 and the proximal notch 377 can at least partly counteract the forceof the biasing member 312, which can reduce or eliminate the amount ofdistal force that the user needs to apply to the vial to maintain it inposition in the device 300. Such a configuration can, for example,reduce the likelihood of the piston 310 and/or the vial beinginadvertently moved proximally by the biasing member 312, which couldresult in a spill or aspiration of blood. In some variants, theresilient arms 358 and the proximal notch 377 engage when the distal endof the vial is near (e.g., less than or equal to about 5 mm, about 7 mm,or about 10 mm) or abutted against the partition 383 of the sleeve 316.

In various embodiments, if further samples of blood are desired, thevial can be disengaged from the device 300 by moving the vial 300proximally, thereby extracting the proximal end 305 of the needle 302from the vial. In certain implementations, when the vial is movedproximally, the biasing member 312 will encourage the piston 310proximally. In some embodiments, removal of the vial allows the piston310 and/or the boot 314 to generally return to the ready-to-operateposition (e.g., having a portion disposed proximal of the proximal end305 of the needle 302). In certain implementations, as the vial isremoved from the device 300, the resilient arms 358 of the intermediatemember 308 re-engage with the distal notch 377′ of the piston 310, whichcan provide a slight resistance against incidental contact with thepiston 310. After disengagement of the vial, another vial or vials canbe engaged with the device 300.

In some embodiments, after the desired number of samples has beencollected, the vial can be disengaged from the device 300 and the device300 can be disengaged from the medical connector. For example, themedical connector interface 324 can be rotated out of threadedengagement with a needleless IV access device. In certainimplementations, after the device 300 has been disengaged from themedical connector, the sleeve 316 is removed from the intermediatemember 308, such as by unscrewing the threaded connection. In someembodiments, removal of the sleeve 316 disengages the wedge 385 from thestruts 357 of the intermediate member 308. In certain implementations,such disengagement results in the struts 357 of the intermediate member308 re-engaging with the windows 366 of the piston 310, therebygenerally locking the piston 310 (e.g., inhibiting further distalmovement), which can reduce the likelihood of a person being stuck withthe proximal end 305 of the needle 302.

Furthermore, similar to the sleeve 216 of the device 200 and thediscussion above in connection with FIG. 27, in some embodiments, thesleeve 316 can be disposed of as standard waste or non-“sharps” waste.Removal of the sleeve 316 can reduce the weight of the device 300 thatis disposed of as “sharps” waste, which in turn can reduce the cost todispose of the device 300. In some embodiments, a method ofmanufacturing or providing a blood connection device 300 can includeinstructing healthcare providers and/or patients to dispose of a portionof the device 300 in a “sharps” receptacle and to dispose of anotherportion of the device 300 in an ordinary and/or conventional medicalrefuse receptacle.

Some embodiments of device 300 may be configured for disposal ashazardous waste or other non-“sharps” waste. Certain variants may bedisposable as non-“sharps” waste at least partly due to the needle 302being substantially, substantially entirely, or entirely contained inthe device 300 after the device 300 has been used (e.g., in a bloodcollection procedure), thereby greatly reducing or eliminating thepotential of the needle 302 to pierce or rupture the disposal container(e.g., a plastic bag or cardboard box) and/or to produce skin lacerationor puncture injuries. Some variants of the device 300 may be disposableas non-“sharps” waste because, for example, the device 300 canautomatically and passively secure the piston 310 after the device 300has been used.

In certain configurations, portions of the device 300 can form aprotective enclosure around the needle 302, thereby reducing oreliminating the need for disposing the device 300 in a separate “sharps”container. For example, the connector member 306, intermediate member308, and piston 310 can form a protective enclosure around the needle302 after the device 300 has been used. In certain embodiments, theprotective enclosure may render the device 300 suitable for disposal asnon-“sharps” waste, such as hazardous waste. In some variants, theconnector member 306 and/or piston 310 include sealing elements (e.g., aresilient flap, septum, or otherwise) that are configured to generallyseal the distal aperture 323 of the connector member 306 and/or thehollow proximal end 372 of the piston 310 at least after the device 300has been used, thereby reducing the possibility of fluid (e.g., blood)from the needle 302 leaking from the device 300.

In certain embodiments, before, during, or after assembly, the bloodcollection safety device 100-100 c, 200, 300 is cleaned and/orsterilized. In some variants, the blood collection safety device 100-100c, 200, 300 is individually packaged. In some implementations, a bloodcollection kit comprises the blood collection safety device 100-100 c,200, 300 and a surface prepatory supply, such as a wipe comprising adisinfectant, antiseptic, or other sanitizing agent. Some variants ofthe kit also include a blood collection vial.

Although the safety device has been disclosed in the context of certainpreferred embodiments and examples for blood collection, it will beunderstood by those skilled in the art that the device extends beyondthe specifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. For example, the locking and/or reuse inhibiting features couldbe used in a variety of medical and non-medical fields. Within themedical field, the device can be used in applications or uses that areseparate from and/or do not involve blood collection. It should beunderstood that various features and aspects of the disclosedembodiments can be combined with or substituted for one another in orderto form varying modes of the blood collection safety device. Thus, it isintended that the scope of the device herein-disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims that follow.

1. A method of manufacturing a blood collection safety device having atleast a first mode and a second mode, the method comprising: providing ahousing having a longitudinal axis and a needle; providing a firstneedle cover; providing a second needle cover, the second needle coverconfigured to engage a blood collection vial, the second needle cover atleast partly nested along the longitudinal axis with the first needlecover in the first mode; and compressing a biasing member between thefirst needle cover and the second needle cover, the biasing memberconfigured to encourage the first needle cover and the second needlecover to move to spaced apart positions along the longitudinal axis inthe second mode.
 2. The method of claim 1, wherein, in the second mode,a portion of the first needle cover is positioned distal of the distaltip of the needle.
 3. The method of claim 1, wherein the first needlecover further comprises an extension locking member.
 4. The method ofclaim 1, wherein the first needle cover further comprises a rotationallocking member and the housing further comprises a cam member.
 5. Themethod of claim 1, wherein, in the first mode, the first needle coverlongitudinally receives at least part of the second needle cover.
 6. Themethod of claim 1, wherein the second needle cover further comprises aplurality of tracks, and the first needle cover further comprises aguide member configured to slide along the plurality of tracks.
 7. Themethod of claim 6, wherein at least one of the tracks is an angledtrack, the angled track being angled with respect to the longitudinalaxis.
 8. The method of claim 7, wherein the sliding of the guide memberin the angled track rotates the second needle cover.
 9. The method ofclaim 1, wherein the housing further comprises a needle supportconnected with the needle and the second needle cover further comprisesa channel configured to slidingly receive the needle support.
 10. Amethod of using a blood collection safety device having a distal needlecover, a proximal needle cover, and a needle, the method comprising:positioning a distal end of the needle against a patient's skin;applying an amount of distally-directed force on the blood collectionsafety device such that the distal end of the needle pierces thepatient's skin; engaging a blood collection vial with a proximal end ofthe needle, thereby placing the needle in fluid communication with thevial; allowing blood to flow from the patient into the vial via theneedle; reducing the amount of distally-directed force such that thedistal needle cover is moved distally by a biasing member of the bloodcollection safety device; removing the distal end of the needle from thepatient's skin; disengaging the blood collection vial and the proximalend of the needle; forming at least some of a protective enclosurearound the needle by: positioning at least a portion of the distalneedle cover distal of the distal end of the needle, thereby coveringthe distal end of the needle; positioning at least a portion of theproximal needle cover proximal of the proximal end of the needle,thereby covering the proximal end of the needle; passively securing thedistal needle cover to prevent the distal end of the needle from movingdistal of the portion of the distal needle cover; and passively securingthe proximal needle cover to prevent the proximal end of the needle frommoving proximal of the portion of the proximal needle cover; anddisposing of the blood collection safety device in a non-sharps wastereceptacle.
 11. A method of using a blood collection safety devicehaving a distal end, a proximal needle cover, and a needle, the methodcomprising: connecting the distal end of the blood collection devicewith a medical connector configured to be in fluid communication with apatient's blood; placing the needle in fluid communication with themedical connector; engaging a blood collection vial with a proximal endof the needle, thereby placing the needle in fluid communication withthe vial; allowing blood to flow from the patient into the vial via themedical connector and the needle; disengaging the blood collection vialand the proximal end of the needle; forming at least some of aprotective enclosure around the needle by: positioning at least aportion of the proximal needle cover proximal of the proximal end of theneedle, thereby covering the proximal end of the needle; and passivelysecuring the proximal needle cover to prevent the proximal end of theneedle from moving proximal of the portion of the proximal needle cover;and disposing of the blood collection safety device in a non-sharpswaste receptacle.